Medical Devices; Exemption From Premarket Notification and Reserved Devices; Class I

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 862, 864, 866, 868, 870, 872, 874, 876, 878, 880, 882,

884, 886, 888, 890, and 892

[Docket No. 98N-0009]

Medical Devices; Exemption From Premarket Notification and

Reserved Devices; Class I

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending its

classification regulations to designate class I devices that are exempt

from the premarket notification requirements, subject to certain

limitations, and to designate those class I devices that remain subject

to premarket notification requirements under the new statutory criteria

for premarket notification requirements. The devices FDA is designating

as exempt do not include class I devices that have been previously

exempted by regulation from the premarket notification requirements.

This action is being taken under the Federal Food, Drug, and Cosmetic

Act (the act), as amended by the Medical Device Amendments of 1976 (the

1976 amendments), the Safe Medical Devices Act of 1990 (SMDA), and the

FDA Modernization Act of 1997 (FDAMA). FDA is taking this action in

order to implement a requirement of FDAMA. Elsewhere in this issue of

the Federal Register, FDA is announcing that it is withdrawing proposed

rules to revoke existing exemptions from premarket notification for two

devices.

DATES: This regulation is effective February 14, 2000.

FOR FURTHER INFORMATION CONTACT: Heather S. Rosecrans, Center for

Devices and Radiological Health (HFZ-404), Food and Drug

Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-

1190.

SUPPLEMENTARY INFORMATION:

I. Statutory Background

Under section 513 of the act (21 U.S.C. 360c), FDA must classify

devices into one of three regulatory classes: Class I, class II, or

class III. FDA classification of a device is determined by the amount

of regulation necessary to provide a reasonable assurance of safety and

effectiveness. Under the 1976 amendments (Public Law 94-295), as

amended by the SMDA (Public Law 101-629), devices are to be classified

into class I (general controls) if there is information showing that

the general controls of the act are sufficient to ensure safety and

effectiveness; into class II (special controls), if general controls,

by themselves, are insufficient to provide reasonable assurance of

safety and effectiveness, but there is sufficient information to

establish special controls to provide such assurance; and into class

III (premarket approval), if there is insufficient information to

support classifying a device into class I or class II and the device is

a life-sustaining or life-supporting device, or is for a use which is

of substantial importance in preventing impairment of human health, or

presents a potential unreasonable risk of illness or injury.

Most generic types of devices that were on the market before the

date of the 1976 amendments (May 28, 1976) (generally referred to as

preamendments devices) have been classified by FDA under the procedures

set forth in section 513(c) and (d) of the act through the issuance of

classification regulations into one of these three regulatory classes.

Devices introduced into interstate commerce for the first time on or

after May 28, 1976 (generally referred to as postamendments devices)

are classified through the premarket notification process under section

510(k) of the act (21 U.S.C. 360(k)). Section 510(k) of the act and the

implementing regulations, part 807 (21 CFR part 807), require persons

who intend to market a new device to submit a premarket notification

report (510(k)) containing information that allows FDA to determine

whether the new device is substantially equivalent within the meaning

of section 513(i) of the act to a legally marketed device that does not

require premarket approval. Unless exempted from premarket notification

requirements, persons may not market a new device under section 510(k)

of the act, unless they receive a substantial equivalence order from

FDA or an order reclassifying the device into class I or class II,

under section 513(f) of the act.

On November 21, 1997, the President signed FDAMA into law (Public

Law 105-115). Section 206 of FDAMA, in part, added a new section 510(l)

to the act. Under section 206 of FDAMA, new section 510(l) of the act

became effective on February 19, 1998. New section 510(l) of the act

provides that a class I device is exempt from the premarket

notification requirements under section 510(k) of the act, unless the

device is intended for a use which is of substantial importance in

preventing impairment of human health or it presents a potential

unreasonable risk of illness or injury. This document refers to devices

that FDA believes meet these criteria as ``reserved.'' FDA has

evaluated all class I devices to determine which device types should be

subject to premarket notification requirements.

In developing the list of reserved devices, the agency considered

its experience in reviewing premarket notifications for these device

types, focusing on the risk inherent with the device and/or the disease

being treated or diagnosed. FDA believes that the devices listed as

reserved are intended for a use that is of substantial importance in

preventing impairment of human health or present a potential

unreasonable risk of illness or injury.

II. Limitations on Exemptions

FDA believes that the generic types of class I devices listed

herein, in addition to a vast majority of class I devices previously

exempted, should be exempt from the premarket notification requirements

under section 510(l) of the act. FDA further believes, however, that

these generic device categories should be exempt only to the extent

that they have existing or reasonably foreseeable characteristics of

commercially distributed devices within that generic type or, in the

case of in vitro diagnostic devices (IVD's), only to the extent that

misdiagnosis as a result of using the device would not be associated

with high morbidity or mortality. FDA believes that certain changes to

devices within a generic device type that is generally exempt may make

the device intended for a use that is of substantial importance in

preventing impairment of human health or may make the device present a

potential unreasonable risk of illness or injury. Accordingly, devices

changed in this manner would fall within the reserved criteria under

section 510(l) of the act and would require premarket notification.

FDA believes that devices that have different intended uses than

legally marketed devices in that generic device type present a

potential unreasonable risk of illness or injury because their safety

and effectiveness characteristics

[[Page 2297]]

are unknown. Moreover, FDA believes that IVD's are intended for a use

that is of substantial importance in preventing impairment of human

health or present a potential unreasonable risk of illness or injury,

if misdiagnosis, as a result of using the device, could result in high

morbidity or mortality.

Accordingly, because FDA believes that devices incorporating the

characteristics described above fit within the reserved criteria under

section 510(l) of the act, FDA considers any class I device to be

subject to premarket notification requirements if the device: (1) Has

an intended use that is different from the intended use of a legally

marketed device in that generic type of device (e.g., the device is

intended for a different medical purpose, or the device is intended for

lay use instead of use by health care professionals); or (2) operates

using a different fundamental scientific technology than that used by a

legally marketed device in that generic type of device (e.g., a

surgical instrument cuts tissue with a laser beam rather than with a

sharpened metal blade, or an IVD detects or identifies infectious

agents by using a deoxyribonucleic acid (DNA) probe or nucleic acid

hybridization or amplification technology rather than culture or

immunoassay technology); or (3) is an in vitro device that is intended:

(a) For use in the diagnosis, monitoring, or screening of neoplastic

diseases with the exception of immunohistochemical devices; (b) for use

in screening or diagnosis of familial and acquired genetic disorders,

including inborn errors of metabolism; (c) for measuring an analyte

that serves as a surrogate marker for screening, diagnosis, or

monitoring life threatening diseases such as acquired immune deficiency

syndrome (AIDS), chronic or active hepatitis, tuberculosis, or

myocardial infarction or to monitor therapy; (d) to assess the risk of

cardiovascular diseases; (e) for use in diabetes management; (f) to

identify or infer the identity of a microorganism directly from

clinical material; (g) for detection of antibodies to microorganisms

other than immunoglobulin G (IgG) and IgG assays when the results are

not qualitative, or are used to determine immunity, or the assay is

intended for use in matrices other than serum or plasma; (h) for

noninvasive testing as defined in Sec. 812.3(k) (21 CFR 812.3(k)); and

(9) for near patient testing (point of care). FDA is revising

Secs. 862.9, 864.9, and 866.9 (21 CFR 862.9, 864.9, and 866.9) to

incorporate these revised limitations on exemptions for IVD's. FDA

believes that these limitations, for the reasons described previously,

are appropriate for IVD's.

FDA is also amending all current limitations on exemptions sections

(21 CFR 862.9, 864.9, 866.9, 868.9, 870.9, 872.9, 874.9, 876.9, 878.9,

880.9, 882.9, 884.9, 886.9, 888.9, 890.9, and 892.9) in two ways.

First, the limitations language clarifies that these limitations apply

to class II, as well as class I devices. On January 21, 1998 (63 FR

3142), FDA published a list of exempted class II devices, subject to

certain limitations. Under section 510(m)(1) of the act, as added by

FDAMA, FDA was provided the authority to exempt these class II devices

from premarket notification upon issuance of a notice. FDA codified

these exemptions, including the limitations described in the January

21, 1998, Federal Register notice, by issuance of a final rule on

November 3, 1998 (63 FR 59222).

The limitations language in this document for class I devices is

identical to those limitations for class II devices that became

effective on January 21, 1998. Accordingly, the limitations sections

state that the scope of these limitations apply to class II, as well as

class I devices.

Second, FDA is amending the limitations language to state that

premarket notifications must be submitted for class I exempt devices if

the intended use is different than the ``legally marketed devices in

that generic type.'' Currently, the limitations in each classification

regulation (e.g., Secs. 862.9, 864.9, etc.) state that manufacturers

must submit premarket notifications for class I exempt devices when

``[t]he device is intended for a use different from its intended use

before May 28, 1976, or the device is intended for a use different from

the intended use of a preamendments device to which it had been

determined to be substantially equivalent;''. Devices that have an

intended use that differs from any legally marketed device are not

exempt because those devices present a potential unreasonable risk of

illness or injury because their safety and effectiveness

characteristics are unknown. Manufacturers of such devices must submit

a premarket notification and the agency will determine if they are

substantially equivalent to other legally marketed devices in that

generic device type.

In addition to the general limitations on exemptions applicable to

all class I devices that are described previously, certain devices

within a generic class also remain subject to the premarket

notification requirements because they either are intended for a use

that is of substantial importance in preventing impairment of human

health or they present a potential unreasonable risk of illness or

injury. For example, elsewhere in this document, FDA states that liquid

bandages are generally exempt from the premarket notification

requirements, but a subcategory of those devices, those intended for

treatment of burns and other open wounds, remains subject to the

premarket notification requirements. FDA believes that liquid bandages

intended for burns and other open wounds should remain subject to this

requirement because they are of substantial importance in preventing

impairment of human health by helping to prevent infections.

FDA also advises that an exemption from the requirement of

premarket notification does not mean that the device is exempt from any

other statutory or regulatory requirements, unless such exemption is

explicitly provided by order or regulation.

The limitations in each classification regulation apply to the

premarket notification exemptions for each generic device classified in

each section. In addition to mentioning the limitations generally in

each classification regulation, FDA specifically states in the

classification sections for each generic device that is newly exempted

under section 510(l) of the act that the exemptions are subject to

limitations. For example, with this regulation Sec. 862.1200 states

that the corticosterone test system ``is exempt from the premarket

notification procedures in subpart E of part 807 of this chapter

subject to Sec. 862.9.'' (Emphasis added.) FDA is adding this language

specifically referring to the limitations language for clarity and

convenience.

Individual device classification sections that have been codified

previously that are exempt from premarket notification requirements,

subject to limitations, do not specifically refer to the general

limitations section. For these classifications, FDA intends to codify

language in the near future that will mention the limitations sections

in each device classification.

III. Analysis of Comments

In the Federal Register of February 2, 1998 (63 FR 5387), FDA

published a list of devices it considered reserved and that require

premarket notification and a list of devices it believed met the

exemption criteria in FDAMA. FDA invited comments on the February 2,

1998, notice.

In the Federal Register of November 12, 1998 (63 FR 63222), after

reviewing the comments submitted on the February 2, 1998, Federal

Register

[[Page 2298]]

notice, FDA proposed to designate which devices require premarket

notification, and which are exempt, subject to limitations, under

notice and comment rulemaking proceedings under new section 510(l) of

the act. FDA received four comments in response to the proposed rule.

The following is FDA's response to those comments.

1. One comment in regard to unscented menstrual pads

(Sec. 884.5435) (21 CFR 884.5435)) stated that: (1) Interlabial pads do

not contact vaginal tissue; (2) interlabial pads should not be grouped

with reusable menstrual pads in the regulation because they have

different risks; and (3) the term ``intralabial'' is not accurate and

the correct nomenclature is ``interlabial.''

Both interlabial pads and reusable pads are types of unscented

menstrual pads that meet the reserved criteria, and, therefore, must

meet the premarket notification requirements. Other types of unscented

menstrual pads are exempt. Although FDA agrees that interlabial pads do

not contact vaginal tissue and that interlabial pads present different

risks than reusable menstrual pads, both types of pads still meet the

reserved criteria. FDA did not group these types of pads as reserved

devices because they had the same risks but has determined both need to

undergo premarket review based on their risks independently. FDA agrees

that the term the term ``interlabial'' is more appropriate than the

term ``intralabial'' and is using the term ``interlabial'' in the final

rule and Sec. 884.5435.

2. Another comment requested clarification of the scope of the

classification and exemption of the blood bank centrifuge for in vitro

diagnostic use (Sec. 864.9275 (21 CFR 864.9275)). More specifically,

the comment asked whether centrifuges used to separate whole blood into

its component parts for eventual transfusion to patients are exempt

from premarket notification.

Section 864.9275 applies to the small tabletop centrifuges used to

spin down test tubes of blood samples used in immunohematology tests.

This classification does not include a centrifuge used to separate or

prepare blood components for transfusion, which is classified in class

II as an autotransfusion apparatus (21 CFR 868.5830) and is subject to

premarket notification requirements.

3. One comment requested clarification about how the ``Limitations

to exemption'' apply to a device labeled for general use, such as 21

CFR 862.2300 Colorimeter, photometer, or spectrophotometer for clinical

use or 21 CFR 862.2560 Fluorometer for clinical use. Section 862.9(c)

states the exemption from 510(k) of the act does not apply if the

device is intended, ``for measuring an analyte that serves as a

surrogate marker for screening, diagnosis, or monitoring life-

threatening diseases such as acquired immune deficiency syndrome

(AIDS), chronic or active hepatitis, tuberculosis, or myocardial

infarction or to monitor therapy.''

The ``Limitations to exemption'' refer to the device, as labeled.

If the device has been labeled as a general purpose device, and was

exempt, and it is now to be labeled for a specific indication, such as

cytomegalovirus, a new 510(k) must be submitted and cleared before that

specific indication can be marketed.

4. One comment regarding the ``Limitations to exemption'' objected

to the revocation of the premarket notification exemption for the

cardiopulmonary bypass accessory equipment involving an electrical

connection to the patient prior to up-classifying them into class II in

order to comply with the performance standard for cables and leads. The

comment stated that many of the cardiopulmonary bypass devices did not

involve a cable or lead.

FDA has reviewed the devices that fall under this regulation and

agrees that many of the devices do not involve electrical connections

to the patient. On August 9, 1999 (64 FR 43114), FDA published a

proposed rule to reclassify three devices into class II in order to

make them subject to the performance standard for electrode lead wires

and patient cables. These three devices are: (1) Cardiopulmonary bypass

accessory equipment that involves an electrical connection to the

patient, (2) the goniometer device, and (3) the electrode cable. Under

this proposal, cardiopulmonary bypass accessory equipment that does not

involve an electrical connection to the patient would remain in class I

and would be exempt from the premarket notification requirements.

Because FDA believes that compliance with the performance standard for

electrode lead wires and patient cables would provide adequate

assurance of the safety and effectiveness of these devices, the

proposal provides that these devices would be exempt from the premarket

notification requirements.

Elsewhere in this issue of the Federal Register, FDA is announcing

that it is withdrawing the proposed rules to revoke the exemptions from

premarket notification for cardiopulmonary bypass accessory equipment

and the electrode cable. Under existing 21 CFR 870.4200

(cardiopulmonary bypass accessory equipment) and 21 CFR 890.1175

(electrode cable), these devices are exempt from the premarket

notification requirements. These exemptions will remain in effect. FDA

expects to finalize the August 9, 1999, proposed rule to make these

devices class II shortly after the comment period ends on November 8,

1999. If the rule is finalized, the devices will be exempt from the

premarket notification requirements and all such devices will be

subject to the performance standard for electrode lead wires and

patient cables, when the second phase of that rule becomes effective on

May 9, 2000. FDA believes that there is no reason to make these devices

subject to premarket notification requirements for the short period of

time between the revocation of the exemption from premarket

notification requirements, as proposed in the November 12, 1998,

Federal Register, and the reclassification and exemption from premarket

notification requirements of these devices, as proposed in the August

9, 1999, Federal Register.

The goniometer device is not a subject of this rule and premarket

notification is still required for these devices under existing 21 CFR

888.1500, until the August 9, 1999, rule is finalized.

5. FDA, on its own initiative, is adding all versions of the

keratoscope (21 CFR 886.1350) to the list of devices exempt from

premarket notification requirements. Previously, only keratoscopes that

did not include computer software were exempt from premarket

notification. In the Federal Register of February 2, 1998 (63 FR 5387),

FDA listed a keratoscope with computer software, as a device that it

believed fell under the exemption criteria in section 510(l) of the

act. The proposed rule, however, did not include the keratoscope with

computer software under those devices FDA proposed to codify as exempt.

Subsequent to the issuance of the proposed rule, FDA received an

inquiry concerning the exemption status of this device. Upon

consideration, FDA does not believe that the keratoscope with computer

software is intended for a use that is of substantial importance in

preventing impairment of human health or that it presents a potential

unreasonable risk of illness or injury and therefore it is exempt from

the premarket notification requirements.

6. FDA, on its own initiative, has made some minor changes in the

sections of each classification, which describe the limitations to

exemptions from section 510(k) of the act. In these sections, FDA lists

certain intended uses or changes that will preclude a device

[[Page 2299]]

from falling within an exemption that is otherwise applicable to a

generic class of devices.

In the final rule, FDA made some nonsubstantive changes in the

introductory paragraph that clarify FDA's reasons for the types of

limitations listed. In proposed sections of each classification

regulation, FDA explained that it listed the limitations because those

types of changes were unforeseeable, and, therefore could significantly

affect safety and effectiveness. The final rule clarifies that FDA also

listed certain types of limitations because any misdiagnosis using

devices for the listed intended uses may be associated with high

morbidity or mortality.

In addition, FDA has made minor changes in describing two of the

intended uses of in vitro devices that would require a premarket

notification. Proposed limitations in paragraph (c)(2) stated that

premarket notifications must be submitted when a device is an in vitro

device that is intended for use in ``screening or diagnosis of familial

and acquired genetic disorders, including inborn errors of

metabolism.'' (Emphasis added.) The proposed rule may have been

interpreted to require premarket notification for only devices that

were used in screening or diagnosis of both familial and acquired

genetic disorders.

FDA intended that devices used in connection with either familial

or acquired genetic disorders be subject to premarket notification

requirements because misdiagnosis of either of these disorders would be

associated with high morbidity or mortality. Accordingly, FDA has

amended the final rule in each limitation section of each

classification regulation to state that premarket notifications must be

submitted when a device is an in vitro device that is intended for use

in ``screening or diagnosis of familial or acquired genetic disorders,

including inborn errors of metabolism.'' (Emphasis added.)

Similarly, FDA stated in the proposed limitation in paragraph

(c)(7) that it would require premarket notification for in vitro

devices intended for detection of antibodies to microorganisms other

than immunoglobulin G (IgG) and IgG assays when the results are not

qualitative * * *.'' The proposed rule could be interpreted to require

premarket notification unless the device were intended for detection of

both IgG and IgG assays. FDA is amending the final rule in the

limitation in paragraph (c)(7) by replacing the word ``and'' with

``or'' to indicate that if an exempt in vitro device is intended to

detect antibodies to either IgG or IgG assays, the device will remain

exempt.

7. FDA, on its own initiative, has added language clarifying the

description of exempted devices in Sec. 880.5090 Liquid bandage (21 CFR

880.5090), Sec. 886.4070 Powered corneal burr (21 CFR 886.4070), and

Sec. 886.4750 Ophthalmic eye shield (21 CFR 886.4750). The proposed

classification descriptions state that the devices were exempt from

premarket notification requirements when used for certain intended

uses. FDA has added language to clarify that the exemption applies only

when the device is used exclusively for the intended uses stated in the

classification descriptions.

For example, proposed Sec. 880.5090 Liquid bandage stated: ``When

used as a skin protectant, the device is exempt from premarket

notification procedures.'' FDA amended final Sec. 880.5090 by adding

the word ``only'' to the text to clarify that if the device were

intended for a use in addition to protecting skin, it would not qualify

for the exemption. Accordingly, final Sec. 880.5090 states: ``When used

only as a skin protectant, the device is exempt from premarket

notification procedures.'' Similarly, FDA has amended final

Secs. 886.4070 Powered corneal burr and 886.4750 Ophthalmic eye shield

by adding the word ``only'' to clarify the exemption does not apply

when the device is used for intended uses not specifically stated in

the regulation.

8. Also, on its own initiative, FDA is revising the description of

the exempted device, rubber dam, in 21 CFR 872.6300(a) to clarify that

this device does not include a rubber dam, which is intended for

prevention of sexually transmitted diseases during oral sex. Such a

device is classified as a condom in 21 CFR 884.5300.

IV. Designation of Devices

The following devices are devices that FDA believes meet the

reserved criteria in section 206 of FDAMA and, therefore, FDA is

codifying the determination that they remain subject to premarket

notification under new section 510(l) of the act:

Table 1--Designations of Reserved Class I Devices

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21 CFR Section Name of Device

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862.1065 Ammonia test system

862.1113 Bilirubin (total and unbound) in the neonate test system

862.1310 Galactose test system

862.1410 Iron (non-heme) test system

862.1415 Iron-binding capacity test system

862.1495 Magnesium test system

862.1580 Phosphorous (inorganic) test system

862.1660 Quality control material (assayed and unassayed) 1

862.1680 Testosterone test system

862.1730 Free tyrosine test system

862.1775 Uric acid test system

862.3050 Breath-alcohol test system

862.3110 Antimony test system

862.3120 Arsenic test system

862.3220 Carbon monoxide test system

862.3240 Cholinesterase test system

862.3280 Clinical toxicology control material (assayed and unassayed) 1

862.3600 Mercury test system

862.3750 Quinine test system

862.3850 Sulfonamide test system

864.7040 Adenosine triphosphate release assay

864.8950 Russell viper venom reagent

864.9050 Blood bank supplies

864.9125 Vacuum-assisted blood collection system 2

864.9195 Blood mixing devices and blood weighing devices 2

[[Page 2300]]

866.2390 Transport culture medium

866.2560 Microbial growth monitor 3

866.2850 Automated zone reader

866.2900 Microbiological specimen collection and transport device

866.3110 Campylobacter fetus serological reagents

866.3120 Chlamydia serological reagents

866.3235 Epstein-Barr virus serological reagents

866.3370 Mycobacterium tuberculosis immunofluorescent reagents

866.3870 Trypanosoma spp. serological reagents

872.3700 Dental mercury

872.4200 Dental handpiece and accessories

872.6250 Dental chair and accessories 4

872.6640 Dental operative unit and accessories 5

872.6710 Boiling water sterilizer

876.5160 Urological clamps for males 6

878.4460 Surgeon's glove

880.5090 Liquid bandage 7

880.5680 Pediatric position holder

880.6250 Patient examination glove

880.6375 Patient lubricant

880.6760 Protective restraint

882.1030 Ataxiagraph

882.1420 Electroencephalogram (EEG) signal spectrum analyzer

882.4060 Ventricular cannula 8

882.4545 Shunt system implantation instrument 9

884.2980(a) Telethermographic system 10

884.2982(a) Liquid crystal thermographic system 11

884.5435 Unscented menstrual pads (interlabial pads and reusable

menstrual pads)

886.4070 Powered corneal burr 12

886.4300 Intraocular lens guide 13

886.4370 Keratome

886.4750 Ophthalmic eye shield (when made of other than plastic or

aluminum)

888.1500 Goniometer

890.3850 Mechanical wheelchair

890.5710 Hot or cold disposable pack 14

892.1100 Scintillation (gamma) camera

892.1110 Positron camera

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\1\ Meets reserved criteria for all assayed and only the unassayed when used for donor screening.

\2\ Meets reserved criteria when automated.

\3\ Meets reserved criteria when automated blood culturing systems.

\4\ Meets reserved criteria when dental chair with the operative unit.

\5\ Meets reserved criteria when it is not an accessory to the unit.

\6\ Meets reserved criteria when devices are for internal use or are used for females.

\7\ Meets reserved criteria for uses other than as a skin protectant.

\8\ Meets reserved criteria if not made of surgical grade stainless steel.

\9\ Meets reserved criteria if not made of surgical grade stainless steel.

\10\ Meets reserved criteria if an adjunct use system.

\11\ Meets reserved criteria if nonelectrically powered or AC-powered adjunctive system.

\12\ Meets reserved criteria if for use other than for removing rust rings.

\13\ Meets reserved criteria if used as folders or injectors for soft or foldable intraocular lenses (IOL's).

\14\ Meets reserved criteria if indicated for use on infants.

FDA is amending the regulations to designate the following devices

as exempt from premarket notification because FDA believes that they do

not meet the reserved criteria under new section 510(l) of the act:

Table 2--Designations of Exempted Class I Devices

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21 CFR Section Name of Device

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862.1030 Alanine amino transferase (ALT/SGPT) test system

862.1040 Aldolase test system

862.1060 Delta-aminolevulinic acid test system

862.1075 Androstenedione test system

862.1080 Androsterone test system

862.1095 Ascorbic acid test system

862.1115 Urinary bilirubin and its conjugates (nonquantitative) test

system

862.1130 Blood volume test system

862.1135 C-peptides of proinsulin test system

862.1165 Catecholamines (total) test system

862.1175 Cholesterol (total) test

862.1180 Chymotrypsin test system

862.1185 Compound S (11-deoxycortisol) test system

862.1195 Corticoids test system

[[Page 2301]]

862.1200 Corticosterone test system

862.1240 Cystine test system

862.1245 Dehydroepiandrosterone (free and sulfate) test system

862.1250 Desoxycorticosterone test system

862.1260 Estradiol test system

862.1265 Estriol test system

862.1270 Estrogens (total, in pregnancy) test system

862.1275 Estrogens (total, nonpregnancy) test system

862.1280 Estrone test system

862.1285 Etiocholanolone test system

862.1300 Follicle-stimulating hormone test system

862.1325 Gastrin test system

862.1330 Globulin test system

862.1335 Glucagon test system

862.1360 Gamma-glutamyl transpeptidase and isoenzymes test system

862.1370 Human growth hormone test system

862.1375 Histidine test system

862.1385 17-Hydroxycorticosteroids (17-ketogenic steroids) test system

862.1390 5-Hydroxyindole acetic acid/serotonin test system

862.1395 17-Hydroxyprogesterone test system

862.1400 Hydroxyproline test system

862.1405 Immunoreactive insulin test system

862.1430 17-Ketosteroids test system

862.1435 Ketones (nonquantitative) test system

862.1450 Lactic acid test system

862.1460 Leucine aminopeptidase test system

862.1465 Lipase test system

862.1475 Lipoprotein test system

862.1485 Luteinizing hormone test system

862.1500 Malic dehydrogenase test system

862.1505 Mucopolysaccharides (nonquantitative) test system

862.1510 Nitrite (nonquantitative) test system

862.1520 5'-Nucleotidase test system

862.1530 Plasma oncometry test system

862.1535 Ornithine carbamyl transferase test system

862.1540 Osmolality test system

862.1542 Oxalate test system

862.1550 Urinary pH (nonquantitative) test system

862.1560 Urinary phenylketones (nonquantitative) test system

862.1570 Phosphohexose isomerase test system

862.1590 Porphobilinogen test system

862.1595 Porphyrins test system

862.1605 Pregnanediol test system

862.1610 Pregnanetriol test system

862.1615 Pregnenolone test system

862.1620 Progesterone test system

862.1625 Prolactin (lactogen) test system

862.1630 Protein (fractionation) test system

862.1645 Urinary protein or albumin (nonquantitative) test system

862.1650 Pyruvate kinase test system

862.1655 Pyruvic acid test system

862.1660 Quality control material (assayed and unassayed) 1

862.1705 Triglyceride test system

862.1725 Trypsin test system

862.1780 Urinary calculi (stones) test system

862.1785 Urinary urobilinogen (nonquantitative) test system

862.1790 Uroporphyrin test system

862.1795 Vanilmandelic acid test system

862.1805 Vitamin A test system

862.1820 Xylose test system

862.2140 Centrifugal chemistry analyzer for clinical use

862.2150 Continuous flow sequential multiple chemistry analyzer for

clinical use

862.2160 Discrete photometric chemistry analyzer for clinical use

862.2170 Micro chemistry analyzer for clinical use

862.2250 Gas liquid chromatography system for clinical use

862.2260 High pressure liquid chromatography system for clinical use

862.2270 Thin-layer chromatography system for clinical use

862.2300 Colorimeter, photometer, or spectrophotometer for clinical use

862.2400 Densitometer/scanner (integrating, reflectance, TLC, or

radiochromatogram) for clinical use

862.2500 Enzyme analyzer for clinical use

862.2540 Flame emission photometer for clinical use

[[Page 2302]]

862.2560 Fluorometer for clinical use

862.2680 Microtitrator for clinical use

862.2700 Nephelometer for clinical use

862.2730 Osmometer for clinical use

862.2750 Pipetting and diluting system for clinical use

862.2850 Atomic absorption spectrophotometer for clinical use

862.2860 Mass spectrometer for clinical use

862.2900 Automated urinalysis system

862.3280 Clinical toxicology control material (assayed and unassayed) 1

864.2280 Cultured animal and human cells

864.3250 Specimen transport and storage container

864.5240 Automated blood cell diluting apparatus

864.6150 Capillary blood collection tube

864.9125 Vacuum-assisted blood collection system 2

864.9185 Blood grouping view box

864.9195 Blood mixing devices and blood weighing devices 2

864.9225 Cell-freezing apparatus and reagents for in vitro diagnostic

use

864.9275 Blood bank centrifuge for in vitro diagnostic use

864.9320 Copper sulphate solution for specific gravity determinations

864.9750 Heat-sealing device

866.2660 Microorganism differentiation and identification device

866.3040 Aspergillus spp. serological reagents

866.3140 Corynebacterium spp. serological reagents

866.3145 Coxsackievirus serological reagents

866.3200 Echinococcus spp. serological reagents

866.3240 Equine encephalomyelitis virus serological reagents

866.3355 Listeria spp. serological reagents

866.3360 Lymphocytic choriomeningitis virus serological reagents

866.3375 Mycoplasma spp. serological reagents

866.3380 Mumps virus serological reagents

866.3405 Poliovirus serological reagents

866.3480 Respiratory syncytial virus serological reagents

866.3500 Rickettsia serological reagents

866.3600 Schistosoma spp. serological reagents

866.3680 Sporothrix schenckii serological reagents

866.3740 Streptococcus spp. serological reagents

866.3850 Trichinella spiralis serological reagents

866.5060 Prealbumin immunological test system

866.5065 Human allotypic marker immunological test system

866.5160 Beta-globulin immunological test system

866.5200 Carbonic anhydrase B and C immunological test

866.5330 Factor XIII, A, S, immunological test system 3

866.5400 Alpha-globulin immunological test system

866.5420 Alpha-1-glycoproteins immunological test system

866.5425 Alpha-2-glycoproteins immunological test system

866.5430 Beta-2-glycoprotein I immunological test system

866.5440 Beta-2-glycoprotein III immunological test system

866.5560 Lactic dehydrogenase immunological test system

866.5570 Lactoferrin immunological test system

866.5590 Lipoprotein X immunological test system

866.5715 Plasminogen immunological test system

866.5735 Prothrombin immunological test system 4

866.5765 Retinol-binding protein immunological test system

866.5890 Inter-alpha trypsin inhibitor immunological test system

868.1910 Esophageal stethoscope

868.5620 Breathing mouthpiece

868.5640 Medicinal nonventilatory nebulizer (atomizer)

868.5675 Rebreathing device

868.5700 Nonpowered oxygen tent

868.6810 Tracheobronchial suction catheter

872.3275(a)(1) Dental cement (zinc oxide-eugenol)

872.3400(b)(1) Karaya and sodium borate with or without acacia denture

adhesive (less than 12 percent sodium borate by weight)

872.3540(b)(1) OTC denture cushion or pad 5

872.6300 Rubber dam and accessories 6

872.6390 Dental floss

874.1070 Short increment sensitivity index (SISI) adapter

874.1100 Earphone cushion for audiometric testing

874.1500 Gustometer

874.1800 Air or water caloric stimulator

874.1925 Toynbee diagnostic tube

874.3300(b)(1) Hearing aid 7

[[Page 2303]]

874.3540 Prosthesis modification instrument for ossicular replacement

surgery

874.4100 Epistaxis balloon

874.4420 Ear, nose, and throat manual surgical instrument

874.5300 Ear, nose, and throat examination and treatment unit

874.5550 Powered nasal irrigator

874.5840 Antistammering device

876.5160 Urological clamp for males 8

876.5210 Enema kit

876.5250(b)(2) Urine collector and accessories 9

876.5980(b)(2) Gastrointestinal tube and accessories 10

878.3250 External facial fracture fixation appliance

878.3910 Noninflatable extremity splint

878.3925 Plastic surgery kit and accessories

878.4040 Surgical apparel 11

878.4100 Organ bag

878.4200 Introduction/drainage catheter and accessories

878.4320 Removable skin clip

878.4680 Nonpowered, single patient, portable suction apparatus

878.4760 Removable skin staple

878.4820 Surgical instrument motors and accessories/attachments

878.4960 Operating tables and accessories and operating chairs and

accessories

880.5090 Liquid bandage 12

880.5270 Neonatal eye pad

880.5420 Pressure infusor for an I.V. bag

882.1200 Two-point discriminator

882.1500 Esthesiometer

882.1750 Pinwheel

882.4060 Ventricular cannula 13

882.4545 Shunt system implantation instrument 14

882.4650 Neurosurgical suture needle

882.4750 Skull punch 15

884.1040 Viscometer for cervical mucus

886.1350 Keratoscope

886.1780 Retinoscope 16

886.1940 Tonometer sterilizer

886.4070 Powered corneal burr 17

886.4300 Intraocular lens guide 18

886.5850 Sunglasses (nonprescription)

890.5180 Manual patient rotation bed

890.5710 Hot or cold disposable pack 19

892.1300 Nuclear rectilinear scanner

892.1320 Nuclear uptake probe

892.1330 Nuclear whole body scanner

892.1350 Nuclear scanning bed

892.1410 Nuclear electrocardiograph synchronizer

892.1890 Radiographic film illuminator

892.1910 Radiographic grid

892.1960 Radiographic intensifying screen

892.1970 Radiographic ECG/respirator, synchronizer

892.2010 Medical image storage device

892.2020 Medical image communications device

892.5650 Manual radionuclide applicator system

892.6500 Personnel protective shield

----------------------------------------------------------------------------------------------------------------

\1\ Exemption is limited to unassayed material, except when used in conjunction with donor screening tests.

\2\ Exemption is limited to manual devices.

\3\ This exemption should not be confused with 21 CFR 864.7290.

\4\ This exemption should not be confused with 21 CFR 864.5425 or 864.7750.

\5\ This exemption does not apply to class III OTC denture cushion as described in 21 CFR 872.3540(b)(2).

\6\ Exemption does not include rubber dam intended for use in preventing transmission of sexually transmitted

diseases through oral sex. Those devices are classified as condoms in 21 CFR 884.5300.

\7\ Exemption is limited to air-conduction hearing aids.

\8\ Exemption does not include devices for internal use or devices used for females.

\9\ Exemption does not include class II devices for a urine collector and accessories intended to be connected

to an indwelling catheter as described in 21 CFR 876.5250(b)(1).

\10\ Exemption is limited to dissolvable nasogastric feed tube guide for the nasogastric tube in 21 CFR

876.5980(b)(2). Exemption does not include class II devices as described in Sec. 876.5980(b)(1).

\11\ Exemption is limited to class I category other than surgical gowns and surgical masks.

\12\ Exemption is limited to uses as a skin protectant.

\13\ Exemption is limited to devices made of surgical grade stainless steel.

\14\ Exemption is limited to devices made of surgical grade stainless steel.

\15\ Exemption should not be confused with 21 CFR 882.4305.

\16\ Exemption is limited to class I battery-powered devices.

\17\ Exemption is limited to rust ring removal.

[[Page 2304]]

\18\ Exemption does not apply if used as folders and injectors for soft or foldable IOL's.

\19\ Exemption does not apply if intended for use on infants

V. Environmental Impact

The agency has determined under 21 CFR 25.30(h) that these actions

are of a type that do not individually or cumulatively have a

significant effect on the human environment. Therefore, neither an

environmental assessment nor an environmental impact statement is

required.

VI. Analysis of Impacts

FDA has examined the impacts of the final rule under Executive

Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612), as

amended by subtitle D of the Small Business Regulatory Fairness Act of

1996 (Public Law 104-121), and the Unfunded Mandates Reform Act of 1995

(Public Law 104-4). Executive Order 12866 directs agencies to assess

all costs and benefits of available regulatory alternatives and, when

regulation is necessary, to select regulatory approaches that maximize

net benefits (including potential economic, environmental, public

health and safety and other advantages distributive impacts and

equity). The agency believes that this rule is consistent with the

regulatory philosophy and principles identified in the Executive Order.

In addition, the rule is not a significant regulatory action as defined

by the Executive Order and so is not subject to review under the

Executive Order.

The Regulatory Flexibility Act requires, if a rule has a

significant impact on a substantial number of small entities, agencies

to analyze regulatory options that would minimize any significant

impact of a rule on small entities. In most cases, the rule would

reduce a regulatory burden by exempting manufacturers of devices

subject to the rule from the requirements of premarket notification.

FDA is requiring premarket notification for three devices that were

previously exempt from premarket notification. These devices are as

follows:

A. Ophthalmic Eye Shield (When Made of Other Than Plastic or Aluminum)

(Sec. 886.4750).

There are six manufacturers of ophthalmic eye shields other than

those made of plastic or aluminum registered with FDA. FDA anticipates

that any premarket notifications that are necessary for these devices

would be simple because FDA would be primarily interested in

information about biocompatibility. FDA estimates that preparation of

such a premarket notification would cost no more than $5,000 and that

there would be no more than 6 premarket notifications per year for a

total annual cost of $30,000.

Six manufacturers are not a substantial number of entities. Based

on data compiled by the Small Business Administration, optical goods

firms with fewer than 500 employees have annual receipts of $1,524,000.

Therefore, the cost per firm of complying with this regulation ($5,000)

does not have a significant impact on these small entities.

B. Quinine Test System (Sec. 862.3750) and Sulfonamide Test System

(Sec. 862.3850).

At this time, there are no firms registered for manufacture of

these devices.

In light of the previous discussion, under the Regulatory

Flexibility Act (5 U.S.C. 605(b)), the agency certifies that the final

rule will not have a significant economic impact on a substantial

number of small entities. The rule also does not trigger the

requirement for a written statement under section 202(a) of the

Unfunded Mandates Reform Act because it does not impose a mandate that

results in an expenditure of $100 million or more by State, local, or

tribal governments in the aggregate, or by the private sector, in any

one year.

VII. Paperwork Reduction Act of 1995

FDA concludes that this rule contains no collections of

information. Therefore, clearance by the Office of Management and

Budget under the Paperwork Reduction Act of 1995 is not required.

List of Subjects

21 CFR Parts 862, 868, 870, 872, 874, 876, 878, 880, 882, 884, 888, and

890

Medical devices.

21 CFR Part 864

Biologics, Blood, Laboratories, Medical devices, Packaging and

containers.

21 CFR Part 866

Biologics, Laboratories, Medical devices.

21 CFR Part 886

Medical devices, Ophthalmic goods and services.

21 CFR Part 892

Medical devices, Radiation protection, X-rays.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under

authority delegated to the Commissioner of Food and Drugs, 21 CFR parts

862, 864, 866, 868, 870, 872, 874, 876, 878, 880, 882, 884, 886, 888,

890, and 892 are amended as follows:

PART 862--CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES

1. The authority citation for 21 CFR part 862 continues to read as

follows:

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

2. Section 862.9 is revised to read as follows:

Sec. 862.9 Limitations of exemptions from section 510(k) of the

Federal Food, Drug, and Cosmetic Act (the act).

The exemption from the requirement of premarket notification

(section 510(k) of the act) for a generic type of class I or II device

is only to the extent that the device has existing or reasonably

foreseeable characteristics of commercially distributed devices within

that generic type or, in the case of in vitro diagnostic devices, only

to the extent that misdiagnosis as a result of using the device would

not be associated with high morbidity or mortality. Accordingly,

manufacturers of any commercially distributed class I or II device for

which FDA has granted an exemption from the requirement of premarket

notification must still submit a premarket notification to FDA before

introducing or delivering for introduction into interstate commerce for

commercial distribution the device when:

(a) The device is intended for a use different from the intended

use of a legally marketed device in that generic type of device; e.g.,

the device is intended for a different medical purpose, or the device

is intended for lay use where the former intended use was by health

care professionals only;

(b) The modified device operates using a different fundamental

scientific technology than a legally marketed device in that generic

type of device; e.g., a surgical instrument cuts tissue with a laser

beam rather than with a sharpened metal blade, or an in vitro

diagnostic device detects or identifies infectious agents by using

deoxyribonucleic acid (DNA) probe or nucleic acid hybridization

technology rather than culture or immunoassay technology; or

(c) The device is an in vitro device that is intended:

[[Page 2305]]

(1) For use in the diagnosis, monitoring, or screening of

neoplastic diseases with the exception of immunohistochemical devices;

(2) For use in screening or diagnosis of familial or acquired

genetic disorders, including inborn errors of metabolism;

(3) For measuring an analyte that serves as a surrogate marker for

screening, diagnosis, or monitoring life-threatening diseases such as

acquired immune deficiency syndrome (AIDS), chronic or active

hepatitis, tuberculosis, or myocardial infarction or to monitor

therapy;

(4) For assessing the risk of cardiovascular diseases;

(5) For use in diabetes management;

(6) For identifying or inferring the identity of a microorganism

directly from clinical material;

(7) For detection of antibodies to microorganisms other than

immunoglobulin G (IgG) or IgG assays when the results are not

qualitative, or are used to determine immunity, or the assay is

intended for use in matrices other than serum or plasma;

(8) For noninvasive testing as defined in Sec. 812.3(k) of this

chapter; and

(9) For near patient testing (point of care).

3. Section 862.1030 is amended by revising paragraph (b) to read as

follows:

Sec. 862.1030 Alanine amino transferase (ALT/SGPT) test system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

4. Section 862.1040 is amended by revising paragraph (b) to read as

follows:

Sec. 862.1040 Aldolase test system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

5. Section 862.1060 is amended by revising paragraph (b) to read as

follows:

Sec. 862.1060 Delta-aminolevulinic acid test system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from premarket notification procedures in subpart E of part 807

of this chapter subject to Sec. 862.9.

6. Section 862.1075 is amended by revising paragraph (b) to read as

follows:

Sec. 862.1075 Androstenedione test system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

7. Section 862.1080 is amended by revising paragraph (b) to read as

follows:

Sec. 862.1080 Androsterone test system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

8. Section 862.1095 is amended by revising paragraph (b) to read as

follows:

Sec. 862.1095 Ascorbic acid test system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

9. Section 862.1115 is amended by revising paragraph (b) to read as

follows:

Sec. 862.1115 Urinary bilirubin and its conjugates (nonquantitative)

test system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

10. Section 862.1130 is amended by revising paragraph (b) to read

as follows:

Sec. 862.1130 Blood volume test system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

11. Section 862.1135 is amended by revising paragraph (b) to read

as follows:

Sec. 862.1135 C-peptides of proinsulin test system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

12. Section 862.1165 is amended by revising paragraph (b) to read

follows:

Sec. 862.1165 Catecholamines (total) test system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

13. Section 862.1175 is amended by revising paragraph (b) to read

as follows:

Sec. 862.1175 Cholesterol (total) test system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

14. Section 862.1180 is amended by revising paragraph (b) to read

as follows:

Sec. 862.1180 Chymotrypsin test system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

15. Section 862.1185 is amended by revising paragraph (b) to read

as follows:

Sec. 862.1185 Compound S (11-deoxycortisol) test system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

16. Section 862.1195 is amended by revising paragraph (b) to read

as follows:

Sec. 862.1195 Corticoids test system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

17. Section 862.1200 is amended by revising paragraph (b) to read

as follows:

Sec. 862.1200 Corticosterone test system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

18. Section 862.1240 is amended by revising paragraph (b) to read

as follows:

Sec. 862.1240 Cystine test system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

19. Section 862.1245 is amended by revising paragraph (b) to read

as follows:

Sec. 862.1245 Dehydroepiandrosterone (free and sulfate) test system.

* * * * *

[[Page 2306]]

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

20. Section 862.1250 is amended by revising paragraph (b) to read

as follows:

Sec. 862.1250 Desoxycorticosterone test system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

21. Section 862.1260 is amended by revising paragraph (b) to read

as follows:

Sec. 862.1260 Estradiol test system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

22. Section 862.1265 is amended by revising paragraph (b) to read

as follows:

Sec. 862.1265 Estriol test system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

23. Section 862.1270 is amended by revising paragraph (b) to read

as follows:

Sec. 862.1270 Estrogens (total, in pregnancy) test system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

24. Section 862.1275 is amended by revising paragraph (b) to read

as follows:

Sec. 862.1275 Estrogens (total, nonpregnancy) test system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

25. Section 862.1280 is amended by revising paragraph (b) to read

as follows:

Sec. 862.1280 Estrone test system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

26. Section 862.1285 is amended by revising paragraph (b) to read

as follows:

Sec. 862.1285 Etiocholanolone test system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

27. Section 862.1300 is amended by revising paragraph (b) to read

as follows:

Sec. 862.1300 Follicle-stimulating hormone test system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

28. Section 862.1325 is amended by revising paragraph (b) to read

as follows:

Sec. 862.1325 Gastrin test system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

29. Section 862.1330 is amended by revising paragraph (b) to read

as follows:

Sec. 862.1330 Globulin test system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

30. Section 862.1335 is amended by revising paragraph (b) to read

as follows:

Sec. 862.1335 Glucagon test system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

31. Section 862.1360 is amended by revising paragraph (b) to read

as follows:

Sec. 862.1360 Gamma-glutamyl transpeptidase and isoenzymes test

system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

32. Section 862.1370 is amended by revising paragraph (b) to read

as follows:

Sec. 862.1370 Human growth hormone test system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

33. Section 862.1375 is amended by revising paragraph (b) to read

as follows:

Sec. 862.1375 Histidine test system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

34. Section 862.1385 is amended by revising paragraph (b) to read

as follows:

Sec. 862.1385 17-Hydroxycorticosteroids (17-ketogenic steroids) test

system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

35. Section 862.1390 is amended by revising paragraph (b) to read

as follows:

Sec. 862.1390 5-Hydroxyindole acetic acid/serotonin test system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

36. Section 862.1395 is amended by revising paragraph (b) to read

as follows:

Sec. 862.1395 17-Hydroxyprogesterone test system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

37. Section 862.1400 is amended by revising paragraph (b) to read

as follows:

Sec. 862.1400 Hydroxyproline test system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

38. Section 862.1405 is amended by revising paragraph (b) to read

as follows:

Sec. 862.1405 Immunoreactive insulin test system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the

[[Page 2307]]

premarket notification procedures in subpart E of part 807 of this

chapter subject to Sec. 862.9.

39. Section 862.1430 is amended by revising paragraph (b) to read

as follows:

Sec. 862.1430 17-Ketosteroids test system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

40. Section 862.1435 is amended by revising paragraph (b) to read

as follows:

Sec. 862.1435 Ketones (nonquantitative) test system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

41. Section 862.1450 is amended by revising paragraph (b) to read

as follows:

Sec. 862.1450 Lactic acid test system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

42. Section 862.1460 is amended by revising paragraph (b) to read

as follows:

Sec. 862.1460 Leucine aminopeptidase test system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

43. Section 862.1465 is amended by revising paragraph (b) to read

as follows:

Sec. 862.1465 Lipase test system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

44. Section 862.1475 is amended by revising paragraph (b) to read

as follows:

Sec. 862.1475 Lipoprotein test system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

45. Section 862.1485 is amended by revising paragraph (b) to read

as follows:

Sec. 862.1485 Luteinizing hormone test system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

46. Section 862.1500 is amended by revising paragraph (b) to read

as follows:

Sec. 862.1500 Malic dehydrogenase test system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

47. Section 862.1505 is amended by revising paragraph (b) to read

as follows:

Sec. 862.1505 Mucopolysaccharides (nonquantitative) test system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

48. Section 862.1510 is amended by revising paragraph (b) to read

as follows:

Sec. 862.1510 Nitrite (nonquantitative) test system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

49. Section 862.1520 is amended by revising paragraph (b) to read

as follows:

Sec. 862.1520 5'-Nucleotidase test system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

50. Section 862.1530 is amended by revising paragraph (b) to read

as follows:

Sec. 862.1530 Plasma oncometry test system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

51. Section 862.1535 is amended by revising paragraph (b) to read

as follows:

Sec. 862.1535 Ornithine carbamyl transferase test system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

52. Section 862.1540 is amended by revising paragraph (b) to read

as follows:

Sec. 862.1540 Osmolality test system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

53. Section 862.1542 is amended by revising paragraph (b) to read

as follows:

Sec. 862.1542 Oxalate test system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

54. Section 862.1550 is amended by revising paragraph (b) to read

as follows:

Sec. 862.1550 Urinary pH (nonquantitative) test system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

55. Section 862.1560 is amended by revising paragraph (b) to read

as follows:

Sec. 862.1560 Urinary phenylketones (nonquantitative) test system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

56. Section 862.1570 is amended by revising paragraph (b) to read

as follows:

Sec. 862.1570 Phosphohexose isomerase test system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

57. Section 862.1590 is amended by revising paragraph (b) to read

as follows:

Sec. 862.1590 Porphobilinogen test system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

58. Section 862.1595 is amended by revising paragraph (b) to read

as follows:

Sec. 862.1595 Porphyrins test system.

* * * * *

[[Page 2308]]

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

59. Section 862.1605 is amended by revising paragraph (b) to read

as follows:

Sec. 862.1605 Pregnanediol test system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

60. Section 862.1610 is amended by revising paragraph (b) to read

as follows:

Sec. 862.1610 Pregnanetriol test system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

61. Section 862.1615 is amended by revising paragraph (b) to read

as follows:

Sec. 862.1615 Pregnenolone test system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

62. Section 862.1620 is amended by revising paragraph (b) to read

as follows:

Sec. 862.1620 Progesterone test system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

63. Section 862.1625 is amended by revising paragraph (b) to read

as follows:

Sec. 862.1625 Prolactin (lactogen) test system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

64. Section 862.1630 is amended by revising paragraph (b) to read

as follows:

Sec. 862.1630 Protein (fractionation) test system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

65. Section 862.1645 is amended by revising paragraph (b) to read

as follows:

Sec. 862.1645 Urinary protein or albumin (nonquantitative) test

system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

66. Section 862.1650 is amended by revising paragraph (b) to read

as follows:

Sec. 862.1650 Pyruvate kinase test system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

67. Section 862.1655 is amended by revising paragraph (b) to read

as follows:

Sec. 862.1655 Pyruvic acid test system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

68. Section 862.1660 is amended by revising paragraph (b) to read

as follows:

Sec. 862.1660 Quality control material (assayed and unassayed).

* * * * *

(b) Classification. Class I (general controls). Except when used

in donor screening tests, unassayed material is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter subject to Sec. 862.9.

69. Section 862.1705 is amended by revising paragraph (b) to read

as follows:

Sec. 862.1705 Triglyceride test system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

70. Section 862.1725 is amended by revising paragraph (b) to read

as follows:

Sec. 862.1725 Trypsin test system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

71. Section 862.1780 is amended by revising paragraph (b) to read

as follows:

Sec. 862.1780 Urinary calculi (stones) test system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

72. Section 862.1785 is amended by revising paragraph (b) to read

as follows:

Sec. 862.1785 Urinary urobilinogen (nonquantitative) test system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

73. Section 862.1790 is amended by revising paragraph (b) to read

as follows:

Sec. 862.1790 Uroporphyrin test system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

74. Section 862.1795 is amended by revising paragraph (b) to read

as follows:

Sec. 862.1795 Vanilmandelic acid test system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

75. Section 862.1805 is amended by revising paragraph (b) to read

as follows:

Sec. 862.1805 Vitamin A test system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

76. Section 862.1820 is amended by revising paragraph (b) to read

as follows:

Sec. 862.1820 Xylose test system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

77. Section 862.2140 is amended by revising paragraph (b) to read

as follows:

Sec. 862.2140 Centrifugal chemistry analyzer for clinical use.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

78. Section 862.2150 is amended by revising paragraph (b) to read

as follows:

Sec. 862.2150 Continuous flow sequential multiple chemistry analyzer

for clinical use.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the

[[Page 2309]]

premarket notification procedures in subpart E of part 807 of this

chapter subject to Sec. 862.9.

79. Section 862.2160 is amended by revising paragraph (b) to read

as follows:

Sec. 862.2160 Discrete photometric chemistry analyzer for clinical

use.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

80. Section 862.2170 is amended by revising paragraph (b) to read

as follows:

Sec. 862.2170 Micro chemistry analyzer for clinical use.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

81. Section 862.2250 is amended by revising paragraph (b) to read

as follows:

Sec. 862.2250 Gas liquid chromatography system for clinical use.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

82. Section 862.2260 is amended by revising paragraph (b) to read

as follows:

Sec. 862.2260 High pressure liquid chromatography system for clinical

use.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

83. Section 862.2270 is amended by revising paragraph (b) to read

as follows:

Sec. 862.2270 Thin-layer chromatography system for clinical use.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9. Particular components of TLC

systems, i.e., the thin-layer chromatography apparatus, TLC atomizer,

TLC developing tanks, and TLC ultraviolet light, are exempt from the

current good manufacturing practice regulations in part 820 of this

chapter, with the exception of Sec. 820.180 of this chapter, with

respect to general requirements concerning records, and Sec. 820.198 of

this chapter, with respect to complaint files.

84. Section 862.2300 is amended by revising paragraph (b) to read

as follows:

Sec. 862.2300 Colorimeter, photometer, or spectrophotometer for

clinical use.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

85. Section 862.2400 is amended by revising paragraph (b) to read

as follows:

Sec. 862.2400 Densitometer/scanner (integrating, reflectance, TLC, or

radiochromatogram) for clinical use.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

86. Section 862.2500 is amended by revising paragraph (b) to read

as follows:

Sec. 862.2500 Enzyme analyzer for clinical use.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

87. Section 862.2540 is amended by revising paragraph (b) to read

as follows:

Sec. 862.2540 Flame emission photometer for clinical use.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

88. Section 862.2560 is amended by revising paragraph (b) to read

as follows:

Sec. 862.2560 Fluorometer for clinical use.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

89. Section 862.2680 is amended by revising paragraph (b) to read

as follows:

Sec. 862.2680 Microtitrator for clinical use.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

90. Section 862.2700 is amended by revising paragraph (b) to read

as follows:

Sec. 862.2700 Nephelometer for clinical use.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

91. Section 862.2730 is amended by revising paragraph (b) to read

as follows:

Sec. 862.2730 Osmometer for clinical use.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

92. Section 862.2750 is amended by revising paragraph (b) to read

as follows:

Sec. 862.2750 Pipetting and diluting system for clinical use.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

93. Section 862.2850 is amended by revising paragraph (b) to read

as follows:

Sec. 862.2850 Atomic absorption spectrophotometer for clinical use.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

94. Section 862.2860 is amended by revising paragraph (b) to read

as follows:

Sec. 862.2860 Mass spectrometer for clinical use.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

95. Section 862.2900 is amended by revising paragraph (b) to read

as follows:

Sec. 862.2900 Automated urinalysis system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 862.9.

96. Section 862.3280 is amended by revising paragraph (b) to read

as follows:

Sec. 862.3280 Clinical toxicology control material.

* * * * *

(b) Classification. Class I (general controls). Except when used

in donor screening, unassayed material is exempt from the premarket

notification procedures in subpart E of part 807 of this chapter

subject to Sec. 862.9.

97. Section 862.3750 is amended by revising paragraph (b) to read

as follows:

[[Page 2310]]

Sec. 862.3750 Quinine test system.

* * * * *

(b) Classification. Class I.

98. Section 862.3850 is amended by revising paragraph (b) to read

as follows:

Sec. 862.3850 Sulfonamide test system.

* * * * *

(b) Classification. Class I.

PART 864--HEMATOLOGY AND PATHOLOGY DEVICES

99. The authority citation for 21 CFR part 864 continues to read

as follows:

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

100. Section 864.9 is revised to read as follows:

Sec. 864.9 Limitations of exemptions from section 510(k) of the

Federal Food, Drug, and Cosmetic Act (the act).

The exemption from the requirement of premarket notification

(section 510(k) of the act) for a generic type of class I or II device

is only to the extent that the device has existing or reasonably

foreseeable characteristics of commercially distributed devices within

that generic type or, in the case of in vitro diagnostic devices, only

to the extent that misdiagnosis as a result of using the device would

not be associated with high morbidity or mortality. Accordingly,

manufacturers of any commercially distributed class I or II device for

which FDA has granted an exemption from the requirement of premarket

notification must still submit a premarket notification to FDA before

introducing or delivering for introduction into interstate commerce for

commercial distribution the device when:

(a) The device is intended for a use different from the intended

use of a legally marketed device in that generic type of device; e.g.,

the device is intended for a different medical purpose, or the device

is intended for lay use where the former intended use was by health

care professionals only;

(b) The modified device operates using a different fundamental

scientific technology than a legally marketed device in that generic

type of device; e.g., a surgical instrument cuts tissue with a laser

beam rather than with a sharpened metal blade, or an in vitro

diagnostic device detects or identifies infectious agents by using

deoxyribonucleic acid (DNA) probe or nucleic acid hybridization

technology rather than culture or immunoassay technology; or

(c) The device is an in vitro device that is intended:

(1) For use in the diagnosis, monitoring, or screening of

neoplastic diseases with the exception of immunohistochemical devices;

(2) For use in screening or diagnosis of familial or acquired

genetic disorders, including inborn errors of metabolism;

(3) For measuring an analyte that serves as a surrogate marker for

screening, diagnosis, or monitoring life-threatening diseases such as

acquired immune deficiency syndrome (AIDS), chronic or active

hepatitis, tuberculosis, or myocardial infarction or to monitor

therapy;

(4) For assessing the risk of cardiovascular diseases;

(5) For use in diabetes management;

(6) For identifying or inferring the identity of a microorganism

directly from clinical material;

(7) For detection of antibodies to microorganisms other than

immunoglobulin G (IgG) or IgG assays when the results are not

qualitative, or are used to determine immunity, or the assay is

intended for use in matrices other than serum or plasma;

(8) For noninvasive testing as defined in Sec. 812.3(k) of this

chapter; and

(9) For near patient testing (point of care).

101. Section 864.2280 is amended by revising paragraph (b) to read

as follows:

Sec. 864.2280 Cultured animal and human cells.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 864.9.

102. Section 864.3250 is amended by revising paragraph (b) to read

as follows:

Sec. 864.3250 Specimen transport and storage container.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 864.9. If the device is not labeled

or otherwise represented as sterile, it is exempt from the current good

manufacturing practice regulations in part 820 of this chapter, with

the exception of Sec. 820.180 of this chapter, with respect to general

requirements concerning records, and Sec. 820.198 of this chapter, with

respect to complaint files.

103. Section 864.5240 is amended by revising paragraph (b) to read

as follows:

Sec. 864.5240 Automated blood cell diluting apparatus.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 864.9.

104. Section 864.6150 is amended by revising paragraph (b) to read

as follows:

Sec. 864.6150 Capillary blood collection tube.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 864.9.

105. Section 864.9125 is amended by revising paragraph (b) to read

as follows:

Sec. 864.9125 Vacuum-assisted blood collection system.

* * * * *

(b) Classification. Class I (general controls). The manual device

is exempt from the premarket notification procedures in subpart E of

part 807 of this chapter subject to Sec. 864.9.

106. Section 864.9185 is amended by revising paragraph (b) to read

as follows:

Sec. 864.9185 Blood grouping view box.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 864.9.

107. Section 864.9195 is amended by revising paragraph (b) to read

as follows:

Sec. 864.9195 Blood mixing devices and blood weighing devices.

* * * * *

(b) Classification. Class I (general controls). The manual device

is exempt from the premarket notification procedures in subpart E of

part 807 of this chapter subject to Sec. 864.9.

108. Section 864.9225 is amended by revising paragraph (b) to read

as follows:

Sec. 864.9225 Cell-freezing apparatus and reagents for in vitro

diagnostic use.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 864.9.

109. Section 864.9275 is amended by revising paragraph (b) to read

as follows:

Sec. 864.9275 Blood bank centrifuge for in vitro diagnostic use.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 864.9.

110. Section 864.9320 is amended by revising paragraph (b) to read

as follows:

[[Page 2311]]

Sec. 864.9320 Copper sulfate solution for specific gravity

determinations.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 864.9.

111. Section 864.9750 is amended by revising paragraph (b) to read

as follows:

Sec. 864.9750 Heat-sealing device.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 864.9.

PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES

112. The authority citation for 21 CFR part 866 continues to read

as follows:

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

113. Section 866.9 is revised to read as follows:

Sec. 866.9 Limitations of exemptions from section 510(k) of the

Federal Food, Drug, and Cosmetic Act (the act).

The exemption from the requirement of premarket notification

(section 510(k) of the act) for a generic type of class I or II device

is only to the extent that the device has existing or reasonably

foreseeable characteristics of commercially distributed devices within

that generic type or, in the case of in vitro diagnostic devices, only

to the extent that misdiagnosis as a result of using the device would

not be associated with high morbidity or mortality. Accordingly,

manufacturers of any commercially distributed class I or II device for

which FDA has granted an exemption from the requirement of premarket

notification must still submit a premarket notification to FDA before

introducing or delivering for introduction into interstate commerce for

commercial distribution the device when:

(a) The device is intended for a use different from the intended

use of a legally marketed device in that generic type of device; e.g.,

the device is intended for a different medical purpose, or the device

is intended for lay use where the former intended use was by health

care professionals only;

(b) The modified device operates using a different fundamental

scientific technology than a legally marketed device in that generic

type of device; e.g., a surgical instrument cuts tissue with a laser

beam rather than with a sharpened metal blade, or an in vitro

diagnostic device detects or identifies infectious agents by using

deoxyribonucleic acid (DNA) probe or nucleic acid hybridization

technology rather than culture or immunoassay technology; or

(c) The device is an in vitro device that is intended:

(1) For use in the diagnosis, monitoring, or screening of

neoplastic diseases with the exception of immunohistochemical devices;

(2) For use in screening or diagnosis of familial or acquired

genetic disorders, including inborn errors of metabolism;

(3) For measuring an analyte that serves as a surrogate marker for

screening, diagnosis, or monitoring life-threatening diseases such as

acquired immune deficiency syndrome (AIDS), chronic or active

hepatitis, tuberculosis, or myocardial infarction or to monitor

therapy;

(4) For assessing the risk of cardiovascular diseases;

(5) For use in diabetes management;

(6) For identifying or inferring the identity of a microorganism

directly from clinical material;

(7) For detection of antibodies to microorganisms other than

immunoglobulin G (IgG) or IgG assays when the results are not

qualitative, or are used to determine immunity, or the assay is

intended for use in matrices other than serum or plasma;

(8) For noninvasive testing as defined in Sec. 812.3(k) of this

chapter; and

(9) For near patient testing (point of care).

114. Section 866.2660 is amended by revising paragraph (b) to read

as follows:

Sec. 866.2660 Microorganism differentiation and identification device.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 866.9.

115. Section 866.3040 is amended by revising paragraph (b) to read

as follows:

Sec. 866.3040 Aspergillus spp. serological reagents.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 866.9.

116. Section 866.3140 is amended by revising paragraph (b) to read

as follows:

Sec. 866.3140 Corynebacterium spp. serological reagents.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 866.9.

117. Section 866.3145 is amended by revising paragraph (b) to read

as follows:

Sec. 866.3145 Coxsackievirus serological reagents.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 866.9.

118. Section 866.3200 is amended by revising paragraph (b) to read

as follows:

Sec. 866.3200 Echinococcus spp. serological reagents.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 866.9.

119. Section 866.3240 is amended by revising paragraph (b) to read

as follows:

Sec. 866.3240 Equine encephalomyelitis virus serological reagents.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 866.9.

120. Section 866.3355 is amended by revising paragraph (b) to read

as follows:

Sec. 866.3355 Listeria spp. serological reagents.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 866.9.

121. Section 866.3360 is amended by revising paragraph (b) to read

as follows:

Sec. 866.3360 Lymphocytic choriomeningitis virus serological reagents.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 866.9.

122. Section 866.3375 is amended by revising paragraph (b) to read

as follows:

Sec. 866.3375 Mycoplasma spp. serological reagents.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 866.9.

123. Section 866.3380 is amended by revising paragraph (b) to read

as follows:

[[Page 2312]]

Sec. 866.3380 Mumps virus serological reagents.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 866.9.

124. Section 866.3405 is amended by revising paragraph (b) to read

as follows:

Sec. 866.3405 Poliovirus serological reagents.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 866.9.

125. Section 866.3480 is amended by revising paragraph (b) to read

as follows:

Sec. 866.3480 Respiratory syncytial virus serological reagents.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 866.9.

126. Section 866.3500 is amended by revising paragraph (b) to read

as follows:

Sec. 866.3500 Rickettsia serological reagents.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 866.9.

127. Section 866.3600 is amended by revising paragraph (b) to read

as follows:

Sec. 866.3600 Schistosoma spp. serological reagents.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 866.9.

128. Section 866.3680 is amended by revising paragraph (b) to read

as follows:

Sec. 866.3680 Sporothrix schenckii serological reagents.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 866.9.

129. Section 866.3740 is amended by revising paragraph (b) to read

as follows:

Sec. 866.3740 Streptococcus spp. serological reagents.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 866.9.

130. Section 866.3850 is amended by revising paragraph (b) to read

as follows:

Sec. 866.3850 Trichinella spiralis serological reagents.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 866.9.

131. Section 866.5060 is amended by revising paragraph (b) to read

as follows:

Sec. 866.5060 Prealbumin immunological test system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 866.9.

132. Section 866.5065 is amended by revising paragraph (b) to read

as follows:

Sec. 866.5065 Human allotypic marker immunological test system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 866.9.

133. Section 866.5160 is amended by revising paragraph (b) to read

as follows:

Sec. 866.5160 Beta-globulin immunological test system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 866.9.

134. Section 866.5200 is amended by revising paragraph (b) to read

as follows:

Sec. 866.5200 Carbonic anhydrase B and C immunological test system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 866.9.

135. Section 866.5330 is amended by revising paragraph (b) to read

as follows:

Sec. 866.5330 Factor XIII, A, S, immunological test system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 866.9. This exemption does not

apply to factor deficiency tests classified under Sec. 864.7290 of this

chapter.

136. Section 866.5400 is amended by revising paragraph (b) to read

as follows:

Sec. 866.5400 Alpha-globulin immunological test system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 866.9.

137. Section 866.5420 is amended by revising paragraph (b) to read

as follows:

Sec. 866.5420 Alpha-1-glycoproteins immunological test system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 866.9.

138. Section 866.5425 is amended by revising paragraph (b) to read

as follows:

Sec. 866.5425 Alpha-2-glycoproteins immunological test system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 866.9.

139. Section 866.5430 is amended by revising paragraph (b) to read

as follows:

Sec. 866.5430 Beta-2-glycoprotein I immunological test system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 866.9.

140. Section 866.5440 is amended by revising paragraph (b) to read

as follows:

Sec. 866.5440 Beta-2-glycoprotein III immunological test system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 866.9.

141. Section 866.5560 is amended by revising paragraph (b) to read

as follows:

Sec. 866.5560 Lactic dehydrogenase immunological test system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 866.9.

142. Section 866.5570 is amended by revising paragraph (b) to read

as follows:

[[Page 2313]]

Sec. 866.5570 Lactoferrin immunological test system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 866.9.

143. Section 866.5590 is amended by revising paragraph (b) to read

as follows:

Sec. 866.5590 Lipoprotein X immunological test system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 866.9.

144. Section 866.5715 is amended by revising paragraph (b) to read

as follows:

Sec. 866.5715 Plasminogen immunological test system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 866.9.

145. Section 866.5735 is amended by revising paragraph (b) to read

as follows:

Sec. 866.5735 Prothrombin immunological test system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 866.9. This exemption does not

apply to multipurpose systems for in vitro coagulation studies

classified under Sec. 864.5425 of this chapter or prothrombin time

tests classified under Sec. 864.7750 of this chapter.

146. Section 866.5765 is amended by revising paragraph (b) to read

as follows:

Sec. 866.5765 Retinol-binding protein immunological test system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 866.9.

147. Section 866.5890 is amended by revising paragraph (b) to read

as follows:

Sec. 866.5890 Inter-alpha trypsin inhibitor immunological test system.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 866.9.

PART 868--ANESTHESIOLOGY DEVICES

148. The authority citation for 21 CFR part 868 continues to read

as follows:

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

149. Section 868.9 is revised to read as follows:

Sec. 868.9 Limitations of exemptions from section 510(k) of the

Federal Food, Drug, and Cosmetic Act (the act).

The exemption from the requirement of premarket notification

(section 510(k) of the act) for a generic type of class I or II device

is only to the extent that the device has existing or reasonably

foreseeable characteristics of commercially distributed devices within

that generic type or, in the case of in vitro diagnostic devices, only

to the extent that misdiagnosis as a result of using the device would

not be associated with high morbidity or mortality. Accordingly,

manufacturers of any commercially distributed class I or II device for

which FDA has granted an exemption from the requirement of premarket

notification must still submit a premarket notification to FDA before

introducing or delivering for introduction into interstate commerce for

commercial distribution the device when:

(a) The device is intended for a use different from the intended

use of a legally marketed device in that generic type of device; e.g.,

the device is intended for a different medical purpose, or the device

is intended for lay use where the former intended use was by health

care professionals only;

(b) The modified device operates using a different fundamental

scientific technology than a legally marketed device in that generic

type of device; e.g., a surgical instrument cuts tissue with a laser

beam rather than with a sharpened metal blade, or an in vitro

diagnostic device detects or identifies infectious agents by using

deoxyribonucleic acid (DNA) probe or nucleic acid hybridization

technology rather than culture or immunoassay technology; or

(c) The device is an in vitro device that is intended:

(1) For use in the diagnosis, monitoring, or screening of

neoplastic diseases with the exception of immunohistochemical devices;

(2) For use in screening or diagnosis of familial or acquired

genetic disorders, including inborn errors of metabolism;

(3) For measuring an analyte that serves as a surrogate marker for

screening, diagnosis, or monitoring life-threatening diseases such as

acquired immune deficiency syndrome (AIDS), chronic or active

hepatitis, tuberculosis, or myocardial infarction or to monitor

therapy;

(4) For assessing the risk of cardiovascular diseases;

(5) For use in diabetes management;

(6) For identifying or inferring the identity of a microorganism

directly from clinical material;

(7) For detection of antibodies to microorganisms other than

immunoglobulin G (IgG) or IgG assays when the results are not

qualitative, or are used to determine immunity, or the assay is

intended for use in matrices other than serum or plasma;

(8) For noninvasive testing as defined in Sec. 812.3(k) of this

chapter; and

(9) For near patient testing (point of care).

150. Section 868.1910 is amended by revising paragraph (b) to read

as follows:

Sec. 868.1910 Esophageal stethoscope.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 868.9.

151. Section 868.5620 is amended by revising paragraph (b) to read

as follows:

Sec. 868.5620 Breathing mouthpiece.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 868.9.

152. Section 868.5640 is amended by revising paragraph (b) to read

as follows:

Sec. 868.5640 Medicinal nonventilatory nebulizer (atomizer).

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 868.9.

153. Section 868.5675 is amended by revising paragraph (b) to read

as follows:

Sec. 868.5675 Rebreathing device.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 868.9.

154. Section 868.5700 is amended by revising paragraph (b) to read

as follows:

Sec. 868.5700 Nonpowered oxygen tent.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in

[[Page 2314]]

subpart E of part 807 of this chapter subject to Sec. 868.9.

155. Section 868.6810 is amended by revising paragraph (b) to read

as follows:

Sec. 868.6810 Tracheobronchial suction catheter.

* * * * *

(b) Classification. Class 1 (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 868.9.

PART 870--CARDIOVASCULAR DEVICES

156. The authority citation for 21 CFR part 870 continues to read

as follows:

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

157. Section 870.9 is revised to read as follows:

Sec. 870.9 Limitations of exemptions from section 510(k) of the

Federal Food, Drug, and Cosmetic Act (the act).

The exemption from the requirement of premarket notification

(section 510(k) of the act) for a generic type of class I or II device

is only to the extent that the device has existing or reasonably

foreseeable characteristics of commercially distributed devices within

that generic type or, in the case of in vitro diagnostic devices, only

to the extent that misdiagnosis as a result of using the device would

not be associated with high morbidity or mortality. Accordingly,

manufacturers of any commercially distributed class I or II device for

which FDA has granted an exemption from the requirement of premarket

notification must still submit a premarket notification to FDA before

introducing or delivering for introduction into interstate commerce for

commercial distribution the device when:

(a) The device is intended for a use different from the intended

use of a legally marketed device in that generic type of device; e.g.,

the device is intended for a different medical purpose, or the device

is intended for lay use where the former intended use was by health

care professionals only;

(b) The modified device operates using a different fundamental

scientific technology than a legally marketed device in that generic

type of device; e.g., a surgical instrument cuts tissue with a laser

beam rather than with a sharpened metal blade, or an in vitro

diagnostic device detects or identifies infectious agents by using

deoxyribonucleic acid (DNA) probe or nucleic acid hybridization

technology rather than culture or immunoassay technology; or

(c) The device is an in vitro device that is intended:

(1) For use in the diagnosis, monitoring, or screening of

neoplastic diseases with the exception of immunohistochemical devices;

(2) For use in screening or diagnosis of familial or acquired

genetic disorders, including inborn errors of metabolism;

(3) For measuring an analyte that serves as a surrogate marker for

screening, diagnosis, or monitoring life-threatening diseases such as

acquired immune deficiency syndrome (AIDS), chronic or active

hepatitis, tuberculosis, or myocardial infarction or to monitor

therapy;

(4) For assessing the risk of cardiovascular diseases;

(5) For use in diabetes management;

(6) For identifying or inferring the identity of a microorganism

directly from clinical material;

(7) For detection of antibodies to microorganisms other than

immunoglobulin G (IgG) or IgG assays when the results are not

qualitative, or are used to determine immunity, or the assay is

intended for use in matrices other than serum or plasma;

(8) For noninvasive testing as defined in Sec. 812.3(k) of this

chapter; and

(9) For near patient testing (point of care).

PART 872--DENTAL DEVICES

158. The authority citation for 21 CFR part 872 continues to read

as follows:

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

159. Section 872.9 is revised to read as follows:

Sec. 872.9 Limitations of exemptions from section 510(k) of the

Federal Food, Drug, and Cosmetic Act (the act).

The exemption from the requirement of premarket notification

(section 510(k) of the act) for a generic type of class I or II device

is only to the extent that the device has existing or reasonably

foreseeable characteristics of commercially distributed devices within

that generic type or, in the case of in vitro diagnostic devices, only

to the extent that misdiagnosis as a result of using the device would

not be associated with high morbidity or mortality. Accordingly,

manufacturers of any commercially distributed class I or II device for

which FDA has granted an exemption from the requirement of premarket

notification must still submit a premarket notification to FDA before

introducing or delivering for introduction into interstate commerce for

commercial distribution the device when:

(a) The device is intended for a use different from the intended

use of a legally marketed device in that generic type of device; e.g.,

the device is intended for a different medical purpose, or the device

is intended for lay use where the former intended use was by health

care professionals only;

(b) The modified device operates using a different fundamental

scientific technology than a legally marketed device in that generic

type of device; e.g., a surgical instrument cuts tissue with a laser

beam rather than with a sharpened metal blade, or an in vitro

diagnostic device detects or identifies infectious agents by using

deoxyribonucleic acid (DNA) probe or nucleic acid hybridization

technology rather than culture or immunoassay technology; or

(c) The device is an in vitro device that is intended:

(1) For use in the diagnosis, monitoring, or screening of

neoplastic diseases with the exception of immunohistochemical devices;

(2) For use in screening or diagnosis of familial or acquired

genetic disorders, including inborn errors of metabolism;

(3) For measuring an analyte that serves as a surrogate marker for

screening, diagnosis, or monitoring life-threatening diseases such as

acquired immune deficiency syndrome (AIDS), chronic or active

hepatitis, tuberculosis, or myocardial infarction or to monitor

therapy;

(4) For assessing the risk of cardiovascular diseases;

(5) For use in diabetes management;

(6) For identifying or inferring the identity of a microorganism

directly from clinical material;

(7) For detection of antibodies to microorganisms other than

immunoglobulin G (IgG) or IgG assays when the results are not

qualitative, or are used to determine immunity, or the assay is

intended for use in matrices other than serum or plasma;

(8) For noninvasive testing as defined in Sec. 812.3(k) of this

chapter; and

(9) For near patient testing (point of care).

160. Section 872.3275 is amended by revising paragraph (a)(2) to

read as follows:

Sec. 872.3275 Dental cement.

(a) * * *

(2) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 872.9.

* * * * *

[[Page 2315]]

161. Section 872.3400 is amended by revising paragraph (b)(1) to

read as follows:

Sec. 872.3400 Karaya and sodium borate with or without acacia denture

adhesive.

* * * * *

(b) Classification. (1) Class I (general controls) if the device

contains less than 12 percent by weight of sodium borate. The class I

device is exempt from the premarket notification procedures in subpart

E of part 807 of this chapter subject to Sec. 872.9.

* * * * *

162. Section 872.3540 is amended by revising paragraph (b)(1) to

read as follows:

Sec. 872.3540 OTC denture cushion or pad.

* * * * *

(b) Classification. (1) Class I if the device is made of wax-

impregnated cotton cloth that the patient applies to the base or inner

surface of a denture before inserting the denture into the mouth. The

device is intended to be discarded following 1 day's use. The class I

device is exempt from the premarket notification procedures in subpart

E of part 807 of this chapter subject to Sec. 872.9.

* * * * *

163. Section 872.6300 is revised to read as follows:

Sec. 872.6300 Rubber dam and accessories.

(a) Identification. A rubber dam and accessories is a device

composed of a thin sheet of latex with a hole in the center intended to

isolate a tooth from fluids in the mouth during dental procedures, such

as filling a cavity preparation. The device is stretched around a tooth

by inserting a tooth through a hole in the center. The device includes

the rubber dam, rubber dam clamp, rubber dam frame, and forceps for a

rubber dam clamp. This classification does not include devices intended

for use in preventing transmission of sexually transmitted diseases

through oral sex; those devices are classified as condoms in

Sec. 884.5300 of this chapter.

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 872.9. If the device is not labeled

or otherwise represented as sterile, it is exempt from the current good

manufacturing practice regulations in part 820 of this chapter, with

the exception of Sec. 820.180 of this chapter, with respect to general

requirements concerning records, and Sec. 820.198 of this chapter, with

respect to complaint files.

164. Section 872.6390 is amended by revising paragraph (b) to read

as follows:

Sec. 872.6390 Dental floss.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 872.9.

165. Section 872.6640 is amended by revising paragraph (b) to read

as follows:

Sec. 872.6640 Dental operative unit and accessories.

* * * * *

(b) Classification. Class I (general controls). Except for dental

operative unit, accessories are exempt from premarket notification

procedures in subpart E of part 807 of this chapter subject to

Sec. 872.9.

PART 874--EAR, NOSE, AND THROAT DEVICES

166. The authority citation for 21 CFR part 874 continues to read

as follows:

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

167. Section 874.9 is revised to read as follows:

Sec. 874.9 Limitations of exemptions from section 510(k) of the

Federal Food, Drug, and Cosmetic Act (the act).

The exemption from the requirement of premarket notification

(section 510(k) of the act) for a generic type of class I or II device

is only to the extent that the device has existing or reasonably

foreseeable characteristics of commercially distributed devices within

that generic type or, in the case of in vitro diagnostic devices, only

to the extent that misdiagnosis as a result of using the device would

not be associated with high morbidity or mortality. Accordingly,

manufacturers of any commercially distributed class I or II device for

which FDA has granted an exemption from the requirement of premarket

notification must still submit a premarket notification to FDA before

introducing or delivering for introduction into interstate commerce for

commercial distribution the device when:

(a) The device is intended for a use different from the intended

use of a legally marketed device in that generic type of device; e.g.,

the device is intended for a different medical purpose, or the device

is intended for lay use where the former intended use was by health

care professionals only;

(b) The modified device operates using a different fundamental

scientific technology than a legally marketed device in that generic

type of device; e.g., a surgical instrument cuts tissue with a laser

beam rather than with a sharpened metal blade, or an in vitro

diagnostic device detects or identifies infectious agents by using

deoxyribonucleic acid (DNA) probe or nucleic acid hybridization

technology rather than culture or immunoassay technology; or

(c) The device is an in vitro device that is intended:

(1) For use in the diagnosis, monitoring, or screening of

neoplastic diseases with the exception of immunohistochemical devices;

(2) For use in screening or diagnosis of familial or acquired

genetic disorders, including inborn errors of metabolism;

(3) For measuring an analyte that serves as a surrogate marker for

screening, diagnosis, or monitoring life-threatening diseases such as

acquired immune deficiency syndrome (AIDS), chronic or active

hepatitis, tuberculosis, or myocardial infarction or to monitor

therapy;

(4) For assessing the risk of cardiovascular diseases;

(5) For use in diabetes management;

(6) For identifying or inferring the identity of a microorganism

directly from clinical material;

(7) For detection of antibodies to microorganisms other than

immunoglobulin G (IgG) or IgG assays when the results are not

qualitative, or are used to determine immunity, or the assay is

intended for use in matrices other than serum or plasma;

(8) For noninvasive testing as defined in Sec. 812.3(k) of this

chapter; and

(9) For near patient testing (point of care).

168. Section 874.1070 is amended by revising paragraph (b) to read

as follows:

Sec. 874.1070 Short increment sensitivity index (SISI) adapter.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 874.9.

169. Section 874.1100 is amended by revising paragraph (b) to read

as follows:

Sec. 874.1100 Earphone cushion for audiometric testing.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 874.9.

170. Section 874.1500 is amended by revising paragraph (b) to read

as follows:

Sec. 874.1500 Gustometer.

* * * * *

[[Page 2316]]

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 874.9. If the device is not labeled

or otherwise represented as sterile, it is exempt from the current good

manufacturing practice regulations in part 820 of this chapter, with

the exception of Sec. 820.180 of this chapter, with respect to general

requirements concerning records, and Sec. 820.198 of this chapter, with

respect to complaint files.

171. Section 874.1800 is amended by revising paragraph (b) to read

as follows:

Sec. 874.1800 Air or water caloric stimulator.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 874.9.

172. Section 874.1925 is amended by revising paragraph (b) to read

as follows:

Sec. 874.1925 Toynbee diagnostic tube.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 874.9.

173. Section 874.3300 is amended by revising paragraph (b) to read

as follows:

Sec. 874.3300 Hearing Aid.

* * * * *

(b) Classification. (1) Class I (general controls) for the air-

conduction hearing aid. The air-conduction hearing aid is exempt from

the premarket notification procedures in subpart E of part 807 of this

chapter subject to Sec. 874.9.

(2) Class II for the bone-conduction hearing aid.

174. Section 874.3540 is amended by revising paragraph (b) to read

as follows:

Sec. 874.3540 Prosthesis modification instrument for ossicular

replacement surgery.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 874.9. If the device is not labeled

or otherwise represented as sterile, it is exempt from the current good

manufacturing practice regulations in part 820 of this chapter, with

the exception of Sec. 820.180 of this chapter, with respect to general

requirements concerning records, and Sec. 820.198 of this chapter, with

respect to complaint files.

175. Section 874.4100 is amended by revising paragraph (b) to read

as follows:

Sec. 874.4100 Epistaxis balloon.

* * * * *

(b) Classification Class I (general controls). The device is exempt

from the premarket notification procedures in subpart E of part 807 of

this chapter subject to Sec. 874.9.

176. Section 874.4420 is amended by revising paragraph (b) to read

as follows:

Sec. 874.4420 Ear, nose, and throat manual surgical instrument.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 874.9.

177. Section 874.5300 is amended by revising paragraph (b) to read

as follows:

Sec. 874.5300 Ear, nose, and throat examination and treatment unit.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 874.9.

178. Section 874.5550 is amended by revising paragraph (b) to read

as follows:

Sec. 874.5550 Powered nasal irrigator.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 874.9.

179. Section 874.5840 is amended by revising paragraph (b) to read

as follows:

Sec. 874.5840 Antistammering device.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 874.9.

PART 876--GASTROENTEROLOGY-UROLOGY DEVICES

180. The authority citation for 21 CFR part 876 continues to read

as follows:

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

181. Section 876.9 is revised to read as follows:

Sec. 876.9 Limitations of exemptions from section 510(k) of the

Federal Food, Drug, and Cosmetic Act (the act).

The exemption from the requirement of premarket notification

(section 510(k) of the act) for a generic type of class I or II device

is only to the extent that the device has existing or reasonably

foreseeable characteristics of commercially distributed devices within

that generic type or, in the case of in vitro diagnostic devices, only

to the extent that misdiagnosis as a result of using the device would

not be associated with high morbidity or mortality. Accordingly,

manufacturers of any commercially distributed class I or II device for

which FDA has granted an exemption from the requirement of premarket

notification must still submit a premarket notification to FDA before

introducing or delivering for introduction into interstate commerce for

commercial distribution the device when:

(a) The device is intended for a use different from the intended

use of a legally marketed device in that generic type of device; e.g.,

the device is intended for a different medical purpose, or the device

is intended for lay use where the former intended use was by health

care professionals only;

(b) The modified device operates using a different fundamental

scientific technology than a legally marketed device in that generic

type of device; e.g., a surgical instrument cuts tissue with a laser

beam rather than with a sharpened metal blade, or an in vitro

diagnostic device detects or identifies infectious agents by using

deoxyribonucleic acid (DNA) probe or nucleic acid hybridization

technology rather than culture or immunoassay technology; or

(c) The device is an in vitro device that is intended:

(1) For use in the diagnosis, monitoring, or screening of

neoplastic diseases with the exception of immunohistochemical devices;

(2) For use in screening or diagnosis of familial or acquired

genetic disorders, including inborn errors of metabolism;

(3) For measuring an analyte that serves as a surrogate marker for

screening, diagnosis, or monitoring life-threatening diseases such as

acquired immune deficiency syndrome (AIDS), chronic or active

hepatitis, tuberculosis, or myocardial infarction or to monitor

therapy;

(4) For assessing the risk of cardiovascular diseases;

(5) For use in diabetes management;

(6) For identifying or inferring the identity of a microorganism

directly from clinical material;

(7) For detection of antibodies to microorganisms other than

immunoglobulin G (IgG) or IgG assays when the results are not

qualitative, or are used to determine immunity, or the assay is

intended for use in matrices other than serum or plasma;

(8) For noninvasive testing as defined in Sec. 812.3(k) of this

chapter; and

[[Page 2317]]

(9) For near patient testing (point of care).

182. Section 876.5160 is amended by revising paragraph (b) to read

as follows:

Sec. 876.5160 Urological clamp for males.

* * * * *

(b) Classification. Class I (general controls). Except when

intended for internal use or use on females, the device is exempt from

the premarket notification procedures in subpart E of part 807 of this

chapter subject to Sec. 876.9.

183. Section 876.5210 is amended by revising paragraph (b) to read

as follows:

Sec. 876.5210 Enema kit.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 876.9. The device is exempt from

the current good manufacturing practice regulations in part 820 of this

chapter, with the exception of Sec. 820.180 of this chapter, with

respect to general requirements concerning records, and Sec. 820.198 of

this chapter, with respect to complaint files.

184. Section 876.5250 is amended by revising paragraph (b)(2) to

read as follows:

Sec. 876.5250 Urine collector and accessories.

* * * * *

(b) * * *

(2) Class I (general controls) for a urine collector and

accessories not intended to be connected to an indwelling catheter. The

class I device is exempt from the premarket notification procedures in

subpart E of part 807 of this chapter subject to Sec. 876.9. If the

device is not labeled or otherwise represented as sterile, it is exempt

from the current good manufacturing practice regulations in part 820 of

this chapter, with the exception of Sec. 820.180 of this chapter, with

respect to the general requirements concerning records, and

Sec. 820.198 of this chapter, with respect to complaint files.

185. Section 876.5980 is amended by revising paragraph (b)(2) to

read as follows:

Sec. 876.5980 Gastrointestinal tube and accessories.

* * * * *

(b) * * *

(2) Class I (general controls) for the dissolvable nasogastric

feed tube guide for the nasogastric tube. The class I device is exempt

from the premarket notification procedures in subpart E of part 807 of

this chapter subject to Sec. 876.9.

PART 878--GENERAL AND PLASTIC SURGERY DEVICES

186. The authority citation for 21 CFR part 878 continues to read

as follows:

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

187. Section 878.9 is revised to read as follows:

Sec. 878.9 Limitations of exemptions from section 510(k) of the

Federal Food, Drug, and Cosmetic Act (the act).

The exemption from the requirement of premarket notification

(section 510(k) of the act) for a generic type of class I or II device

is only to the extent that the device has existing or reasonably

foreseeable characteristics of commercially distributed devices within

that generic type or, in the case of in vitro diagnostic devices, only

to the extent that misdiagnosis as a result of using the device would

not be associated with high morbidity or mortality. Accordingly,

manufacturers of any commercially distributed class I or II device for

which FDA has granted an exemption from the requirement of premarket

notification must still submit a premarket notification to FDA before

introducing or delivering for introduction into interstate commerce for

commercial distribution the device when:

(a) The device is intended for a use different from the intended

use of a legally marketed device in that generic type of device; e.g.,

the device is intended for a different medical purpose, or the device

is intended for lay use where the former intended use was by health

care professionals only;

(b) The modified device operates using a different fundamental

scientific technology than a legally marketed device in that generic

type of device; e.g., a surgical instrument cuts tissue with a laser

beam rather than with a sharpened metal blade, or an in vitro

diagnostic device detects or identifies infectious agents by using

deoxyribonucleic acid (DNA) probe or nucleic acid hybridization

technology rather than culture or immunoassay technology; or

(c) The device is an in vitro device that is intended:

(1) For use in the diagnosis, monitoring, or screening of

neoplastic diseases with the exception of immunohistochemical devices;

(2) For use in screening or diagnosis of familial or acquired

genetic disorders, including inborn errors of metabolism;

(3) For measuring an analyte that serves as a surrogate marker for

screening, diagnosis, or monitoring life-threatening diseases such as

acquired immune deficiency syndrome (AIDS), chronic or active

hepatitis, tuberculosis, or myocardial infarction or to monitor

therapy;

(4) For assessing the risk of cardiovascular diseases;

(5) For use in diabetes management;

(6) For identifying or inferring the identity of a microorganism

directly from clinical material;

(7) For detection of antibodies to microorganisms other than

immunoglobulin G (IgG) or IgG assays when the results are not

qualitative, or are used to determine immunity, or the assay is

intended for use in matrices other than serum or plasma;

(8) For noninvasive testing as defined in Sec. 812.3(k) of this

chapter; and

(9) For near patient testing (point of care).

188. Section 878.3250 is amended by revising paragraph (b) to read

as follows:

Sec. 878.3250 External facial fracture fixation appliance.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 878.9.

189. Section 878.3910 is amended by revising paragraph (b) to read

as follows:

Sec. 878.3910 Noninflatable extremity splint.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 878.9. If the device is not labeled

or otherwise represented as sterile, it is exempt from the current good

manufacturing practice regulations in part 820 of this chapter, with

the exception of Sec. 820.180 of this chapter, with respect to general

requirements concerning records, and Sec. 820.198 of this chapter, with

respect to complaint files.

190. Section 878.3925 is amended by revising paragraph (b) to read

as follows:

Sec. 878.3925 Plastic surgery kit and accessories.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 878.9.

191. Section 878.4040 is amended by revising paragraph (b) to read

as follows:

[[Page 2318]]

Sec. 878.4040 Surgical apparel.

* * * * *

(b) Classification. (1) Class II (special controls) for surgical

gowns and surgical masks.

(2) Class I (general controls) for surgical apparel other than

surgical gowns and surgical masks. The class I device is exempt from

the premarket notification procedures in subpart E of part 807 of this

chapter subject to Sec. 878.9.

192. Section 878.4100 is amended by revising paragraph (b) to read

as follows:

Sec. 878.4100 Organ bag.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 878.9.

193. Section 878.4200 is amended by revising paragraph (b) to read

as follows:

Sec. 878.4200 Introduction/drainage catheter and accessories.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 878.9.

194. Section 878.4320 is amended by revising paragraph (b) to read

as follows:

Sec. 878.4320 Removable skin clip.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 878.9.

195. Section 878.4680 is amended by revising paragraph (b) to read

as follows:

Sec. 878.4680 Nonpowered, single patient, portable suction apparatus.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 878.9.

196. Section 878.4760 is amended by revising paragraph (b) to read

as follows:

Sec. 878.4760 Removable skin staple.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 878.9.

197. Section 878.4820 is amended by revising paragraph (b) to read

as follows:

Sec. 878.4820 Surgical instrument motors and accessories/attachments.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 878.9.

198. Section 878.4960 is amended by revising paragraph (b) to read

as follows:

Sec. 878.4960 Operating tables and accessories and operating chairs

and accessories.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 878.9.

PART 880--GENERAL HOSPITAL AND PERSONAL USE DEVICES

199. The authority citation for 21 CFR part 880 continues to read

as follows:

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

200. Section 880.9 is revised to read as follows:

Sec. 880.9 Limitations of exemptions from section 510(k) of the

Federal Food, Drug, and Cosmetic Act (the act).

The exemption from the requirement of premarket notification

(section 510(k) of the act) for a generic type of class I or II device

is only to the extent that the device has existing or reasonably

foreseeable characteristics of commercially distributed devices within

that generic type or, in the case of in vitro diagnostic devices, only

to the extent that misdiagnosis as a result of using the device would

not be associated with high morbidity or mortality. Accordingly,

manufacturers of any commercially distributed class I or II device for

which FDA has granted an exemption from the requirement of premarket

notification must still submit a premarket notification to FDA before

introducing or delivering for introduction into interstate commerce for

commercial distribution the device when:

(a) The device is intended for a use different from the intended

use of a legally marketed device in that generic type of device; e.g.,

the device is intended for a different medical purpose, or the device

is intended for lay use where the former intended use was by health

care professionals only;

(b) The modified device operates using a different fundamental

scientific technology than a legally marketed device in that generic

type of device; e.g., a surgical instrument cuts tissue with a laser

beam rather than with a sharpened metal blade, or an in vitro

diagnostic device detects or identifies infectious agents by using

deoxyribonucleic acid (DNA) probe or nucleic acid hybridization

technology rather than culture or immunoassay technology; or

(c) The device is an in vitro device that is intended:

(1) For use in the diagnosis, monitoring, or screening of

neoplastic diseases with the exception of immunohistochemical devices;

(2) For use in screening or diagnosis of familial or acquired

genetic disorders, including inborn errors of metabolism;

(3) For measuring an analyte that serves as a surrogate marker for

screening, diagnosis, or monitoring life-threatening diseases such as

acquired immune deficiency syndrome (AIDS), chronic or active

hepatitis, tuberculosis, or myocardial infarction or to monitor

therapy;

(4) For assessing the risk of cardiovascular diseases;

(5) For use in diabetes management;

(6) For identifying or inferring the identity of a microorganism

directly from clinical material;

(7) For detection of antibodies to microorganisms other than

immunoglobulin G (IgG) or IgG assays when the results are not

qualitative, or are used to determine immunity, or the assay is

intended for use in matrices other than serum or plasma;

(8) For noninvasive testing as defined in Sec. 812.3(k) of this

chapter; and

(9) For near patient testing (point of care).

201. Section 880.5090 is amended by revising paragraph (b) to read

as follows:

Sec. 880.5090 Liquid bandage.

* * * * *

(b) Classification. Class I (general controls). When used only as a

skin protectant, the device is exempt from the premarket notification

procedures in subpart E of part 807 of this chapter subject to

Sec. 880.9.

202. Section 880.5270 is amended by revising paragraph (b) to read

as follows:

Sec. 880.5270 Neonatal eye pad.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 880.9. If the device is not labeled

or otherwise represented as sterile, it is exempt from the current good

manufacturing practice regulations in part 820 of this chapter, with

the exception of Sec. 820.180 of this chapter, with respect to general

requirements concerning records, and Sec. 820.198 of this chapter, with

respect to complaint files.

[[Page 2319]]

203. Section 880.5420 is amended by revising paragraph (b) to read

as follows:

Sec. 880.5420 Pressure infusor for an I.V. bag.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 880.9.

PART 882--NEUROLOGICAL DEVICES

204. The authority citation for 21 CFR part 882 continues to read

as follows:

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

205. Section 882.9 is revised to read as follows:

Sec. 882.9 Limitations of exemptions from section 510(k) of the

Federal Food, Drug, and Cosmetic Act (the act).

The exemption from the requirement of premarket notification

(section 510(k) of the act) for a generic type of class I or II device

is only to the extent that the device has existing or reasonably

foreseeable characteristics of commercially distributed devices within

that generic type or, in the case of in vitro diagnostic devices, only

to the extent that misdiagnosis as a result of using the device would

not be associated with high morbidity or mortality. Accordingly,

manufacturers of any commercially distributed class I or II device for

which FDA has granted an exemption from the requirement of premarket

notification must still submit a premarket notification to FDA before

introducing or delivering for introduction into interstate commerce for

commercial distribution the device when:

(a) The device is intended for a use different from the intended

use of a legally marketed device in that generic type of device; e.g.,

the device is intended for a different medical purpose, or the device

is intended for lay use where the former intended use was by health

care professionals only;

(b) The modified device operates using a different fundamental

scientific technology than a legally marketed device in that generic

type of device; e.g., a surgical instrument cuts tissue with a laser

beam rather than with a sharpened metal blade, or an in vitro

diagnostic device detects or identifies infectious agents by using

deoxyribonucleic acid (DNA) probe or nucleic acid hybridization

technology rather than culture or immunoassay technology; or

(c) The device is an in vitro device that is intended:

(1) For use in the diagnosis, monitoring, or screening of

neoplastic diseases with the exception of immunohistochemical devices;

(2) For use in screening or diagnosis of familial or acquired

genetic disorders, including inborn errors of metabolism;

(3) For measuring an analyte that serves as a surrogate marker for

screening, diagnosis, or monitoring life-threatening diseases such as

acquired immune deficiency syndrome (AIDS), chronic or active

hepatitis, tuberculosis, or myocardial infarction or to monitor

therapy;

(4) For assessing the risk of cardiovascular diseases;

(5) For use in diabetes management;

(6) For identifying or inferring the identity of a microorganism

directly from clinical material;

(7) For detection of antibodies to microorganisms other than

immunoglobulin G (IgG) or IgG assays when the results are not

qualitative, or are used to determine immunity, or the assay is

intended for use in matrices other than serum or plasma;

(8) For noninvasive testing as defined in Sec. 812.3(k) of this

chapter; and

(9) For near patient testing (point of care).

206. Section 882.1200 is amended by revising paragraph (b) to read

as follows:

Sec. 882.1200 Two-point discriminator.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 882.9. The device is also exempt

from the current good manufacturing practice regulations in part 820 of

this chapter, with the exception of Sec. 820.180 of this chapter, with

respect to general requirements concerning records, and Sec. 820.198 of

this chapter, with respect to complaint files.

207. Section 882.1500 is amended by revising paragraph (b) to read

as follows:

Sec. 882.1500 Esthesiometer.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 882.9. The device is also exempt

from the current good manufacturing practice regulations in part 820 of

this chapter, with the exception of Sec. 820.180 of this chapter, with

respect to general requirements concerning records, and Sec. 820.198 of

this chapter, with respect to complaint files.

208. Section 882.1750 is amended by revising paragraph (b) to read

as follows:

Sec. 882.1750 Pinwheel.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 882.9.

209. Section 882.4060 is amended by revising paragraph (b) to read

as follows:

Sec. 882.4060 Ventricular cannula.

* * * * *

(b) Classification. Class I (general controls). When made only of

surgical grade stainless steel, the device is exempt from the premarket

notification procedures in subpart E of part 807 of this chapter

subject to Sec. 882.9.

210. Section 882.4545 is amended by revising paragraph (b) to read

as follows:

Sec. 882.4545 Shunt system implantation instrument.

* * * * *

(b) Classification. Class I (general controls). When made only of

surgical grade stainless steel, the device is exempt from the premarket

notification procedures in subpart E of part 807 of this chapter

subject to Sec. 882.9.

211. Section 882.4650 is amended by revising paragraph (b) to read

as follows:

Sec. 882.4650 Neurosurgical suture needle.

* * * * *

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter subject to Sec. 882.9.

212. Section 882.4750 is amended by revising paragraph (b) to read

as follows:

Sec. 882.4750 Skull punch.

* * * * *

(b) Classification. Class I (general controls). T

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