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: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend

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 proposing

to designate 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 Food and Drug Administration Modernization Act of 1997

(FDAMA). FDA is taking this action in order to implement a requirement

of FDAMA.

DATES: Written comments by January 26, 1999.

ADDRESSES: Submit written comments to the Dockets Management Branch

(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,

Rockville, MD 20852.

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

Device 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

[[Page 63223]]

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 (Pub. L. 94-295), as amended

by the SMDA (Pub. L. 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 (Pub. L.

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

the act. Under section 206 of the 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 these

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.

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. Responses to these comments are addressed in this

document.

FDA is now proceeding 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). The

devices FDA is proposing to designate as requiring premarket

notification include five devices that are currently exempt from

premarket notification because FDA believes they meet the reserved

criteria: Quinine test system Sec. 862.3750 (21 CFR 862.3750),

Sulfonamide test system Sec. 862.3850 (21 CFR 862.3850),

Cardiopulmonary bypass accessory equipment Sec. 870.4200 (21 CFR

870.4200), Ophthalmic eye shield Sec. 886.4750 (21 CFR 886.4750) (when

made of other than plastic or aluminum), and Electrode cable

Sec. 890.1175 (21 CFR 890.1175). FDA also is proposing to modify the

limitations language for all class I devices that are currently exempt.

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), for which a 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 are unknown. Moreover, FDA believes

that IVD's that are intended for a use for which a misdiagnosis, as a

result of using the device, could result in high morbidity or

mortality, either 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.

Accordingly, because FDA believes that devices incorporating the

characteristics described previously 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: (a) 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 (b) 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 (c) 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

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devices; (2) for use in screening or diagnosis of familial and 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) to

assess the risk of cardiovascular diseases; (5) for use in diabetes

management; (6) to identify or infer the identity of a microorganism

directly from clinical material; (7) 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;

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

862.9, 864.9, and 866.9) to incorporate the revised limitations on

exemptions for IVD's as set forth previously. FDA believes that these

limitations, for the reasons described previously, are appropriate for

IVD's.

FDA is also proposing to amend 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 proposed 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), as added by FDAMA, FDA was provided the authority to exempt

these class II devices upon issuance of a notice. FDA intends to codify

these exemptions, including the limitations described in the January

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

near future.

The limitations language that is proposed 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 proposed

limitations sections state that the scope of these limitations apply to

class II, as well as class I devices.

Second, FDA is proposing to amend 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

Sec. ______.9 of each classification regulation part (e.g.,

Secs. 862.9, 864.9, etc.) states 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;''.

FDA believes that devices that have an intended use that differs

from any legally marketed device should not be 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 should 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 that FDA

considers applicable to all class I devices that are described

previously, FDA also considers certain devices within a generic class

to 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 it considers liquid bandages generally to be

exempt from the premarket notification requirements, but considers a

subcategory of those devices, those intended for treatment of burns and

other open wounds, to remain 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.

III. Analysis of Comments to the February 2, 1998, Notice

1. One comment proposed that general purpose instruments (21 CFR

862.2140, 862.2150, 862.2160, 862.2170, 862.2250, 862.2260, 862.2300,

862.2400, 862.2500, 862.2540, 862.2560, 862.2680, 862.2700, 862.2730,

and 862.2750) designed to perform clinical testing that provide results

that are intended to be of ``substantial importance in preventing

impairment of human health, or presents a potential risk of illness or

injury'' should not be exempt.

If these devices are not subject to the proposed limitations in

Sec. 862.9, FDA does not believe that premarket notification is

necessary because these devices do not meet the reserved criteria.

Laboratory instruments, like other devices, should be regulated

according to risk and the risk associated with any device is related to

intended use and indications for use. As general purpose instruments,

these devices make no specific claims and their safety and

effectiveness can be reasonably assured by using other general

controls, including design controls (if the instrument includes

computer automation). If the labeling includes indications for specific

analytes on the general purpose instrument, the devices would not meet

the reserved criteria. Under proposed Sec. 862.9, these devices would

be subject to the limitations on exemptions and, therefore, would be

not be exempt from premarket notification. Review of the system and its

indications by FDA would be required through a new premarket

notification.

2. One comment stated that general purpose instruments should not

be exempt from premarket notification because they could be used in a

physician's office or near patient testing (point of care) by

nonlaboratory trained individuals resulting in major threats to patient

health.

FDA believes that these concerns are addressed by the limitations

on exemptions. Under Sec. 862.9(c), devices that are ``for near patient

testing (point of care)'' would be excluded from exemption from

premarket notification.

3. One comment stated that in vitro devices ``intended for use in

screening or diagnosis of familial and acquired genetic disorders

including inborn errors of metabolism'' (21 CFR 862.1330, 862.1335,

862.1560, 862.1595, and 862.1650) and test markers for endocrine

disorders (21 CFR 862.1075, 862.1080, 862.1200, 862.1245, 862.1250,

862.1260, 862.1265, 862.1270, 862.1275, 862.1280, 862.1285, 862.1300,

862.1370, 862.1385, 862.1390, 862.1395, and 862.1620) should be subject

to premarket notification.

FDA agrees that the manufacturer of the IVD's described by the

comment may continue to be required to submit 510(k)'s under the

proposed limitations on exemptions. Proposed limitations in Sec. 862.9

would assure that these products will be subject to premarket

notification requirements if intended for use in screening or diagnosis

of familial or

[[Page 63225]]

acquired genetic disorders or endocrine disorders and will not be

subject to these requirements where the same device is not intended for

these specific high risk indications. FDA, therefore, believes that

these devices should be exempt from premarket notification, subject to

the limitation.

4. One comment suggested that premarket notifications and review

should be required for devices and tests designed to ``identify or

infer the identity of a microorganism directly from clinical

materials,'' including devices classified under Secs. 866.3145,

866.3375, 866.3405, 866.3480, 866.3500 and 866.3740.

FDA agrees. The comment has described one of the limitations on

exemptions in the proposed rule. That limitation would apply to a

number of classifications, including those cited by this comment.

5. One comment suggested that:

Quality control material--(assayed and unassayed) ([21 CFR]

862.1660), must continue to be reviewed so that the FDA oversight

function may continue to identify those manufacturers of quality

control reagents whose manufacturing or testing practices could fail

to ensure a product of appropriate accuracy, stability, and

reliability.

FDA agrees that quality control materials are of critical

importance in laboratory operations. The agency intends to continue to

review assayed quality control materials because it believes they meet

the reserved criteria. FDA believes unassayed quality control

materials, other than those used for donor screening, are appropriate

for exemption from premarket review. Unlike unassayed quality control

materials, assayed quality control materials have specifically labeled

performance levels that are reviewed. The performance of unassayed

quality control materials that are not labeled is not assessed in the

510(k) process and is assessed by the laboratory rather than the

manufacturer. Issues such as stability and reliability for unassayed

quality control materials are adequately addressed by the new quality

systems requirements of current good manufacturing practices. Unassayed

quality control materials for donor screening, however, should not be

exempt because FDA should review the labeling to ensure no specific

performance claims are made.

6. One comment indicated that there is an inconsistency between the

exemptions of the free tyrosine test system (21 CFR 862.1730) and the

galactose test system (21 CFR 862.1310), and the limitations on

exemptions that apply to a device that ``(c) is a in-vitro device that

is intended: * * * (2) for use in screening or diagnosis of familial

and acquired genetic disorders, including inborn errors of

metabolism,'' because all free tyrosine test systems and galactose test

systems are for those uses. Another comment stated that they were

confused about the exemption from premarket notification of free

tyrosine test systems and the limitations on exemptions, as noted

previously.

FDA agrees there was an inconsistency. Because the devices are used

for screening and diagnosis of genetic disorders and are related to

significant morbidity and mortality associated with the disease

entities identified by abnormalities in tyrosine and galactose

metabolism, FDA believes these devices fit within the reserved criteria

and should be added to the list of reserved class I devices that will

continue to require premarket notification submissions.

7. The Health Care Financing Administration (HCFA) raised concerns

about the effect that exemptions may have on HCFA's implementation of

the Clinical Laboratory Improvements Amendments (CLIA). HCFA

subsequently commented that they believed that their concerns could be

addressed without affecting the exemption process.

FDA intends to continue to meet with the HCFA staff to address

these concerns, which relate to inspection procedures in laboratories.

8. One comment stated that FDA had previously exempted the

unscented menstrual pad Sec. 884.5435 (21 CFR 884.5435), from premarket

notification, except for intralabial pads and reusable menstrual pads.

The comment pointed out that the February 2, 1998, notice did not state

whether these devices were reserved or exempted. The comment believes

that FDA meant to exempt them and asked for clarification.

FDA has evaluated the use of intralabial pads and reusable

menstrual pads and believes that they do meet the reserved criteria of

FDAMA. These devices may present a potential unreasonable risk of

illness or injury due to the risk of vaginal laceration, ulceration,

vaginal microflora changes, and other possible adverse effects. FDA is,

therefore, proposing to continue to designate the intralabial pads and

reusable menstrual pads (Sec. 884.5435) as devices that require

premarket notification.

9. One comment stated that FDA should exempt calipers because they

do not meet the class I reserved criteria of FDAMA.

FDA concurs and notes that calipers were exempted on April 5, 1989

(54 FR 13826), under 21 CFR 878.4800 (manual surgical instrument for

general use), subject to 21 CFR 878.9 limitations of exemptions from

section 510(k) of the act.

10. Two comments expressed support for FDA's interpretation of

section 510(l) of FDAMA and the agency's conclusion that devices

identified in 21 CFR 874.3300(b)(1), air conduction hearing aids, meet

the exemption criteria. One comment stated that ``a device will lose

its exemption if its intended use differs, or if it operates with a

different fundamental scientific technology.'' The other comment added

that the society he represented had concerns regarding FDA's

``vigilance in insisting on adherence to FDA regulation governing the

labeling and conditions for sale of hearing aids.''

FDA agrees with the one comment on the scope of the limitations on

exemptions. As far as FDA regulations governing the labeling, the

agency believes that general controls are sufficient to regulate air-

conduction hearing aids and that trade complaints will keep the agency

well informed. The proposed regulation on conditions of sale of hearing

aids is moving toward publication.

11. One comment responded to the February 2, 1998, notice by

submitting a request for classification under section 513(g) of the

act, requesting information regarding the requirements applicable to a

dental water filter system with a treated filter/waterline under 21 CFR

872.6640.

FDA considers this comment a section 513(g) of the act request and

will respond to the submitter in an individual response.

12. One comment requested that the 510(k) the comment submitted for

a class I device classified under Sec. 884.1040 (21 CFR 884.1040)

Viscometer for cervical mucus, be found to be exempt from the section

510(k) requirements of the act. The comment stated that ``the device is

not intended for a use which is of substantial importance in preventing

impairment of human health and does not present a potential

unreasonable risk of illness or injury (``reserved criteria'')'' and

should not be placed under the reserved criteria found in section 206

of FDAMA.

FDA agrees that, generally, viscometers for cervical mucus

(Sec. 884.1040) do not meet the ``reserved'' criteria under FDAMA and

did place this classification regulation on the list of exempted

devices in the February 2, 1998, notice. Consistent with the February

2, 1998, notice, FDA is proposing to designate viscometers for cervical

use exempt from 510(k) requirements. The comment's device,

[[Page 63226]]

however, would use a new matrix for this device. FDA believes that this

represents a different intended use that would make this device subject

to the limitations on exemptions and, therefore, ineligible for

exemption.

13. One comment questioned the limitations on exemptions stated in

the February 2, 1998, notice, particularly the limitations applicable

to IVD's that are noninvasive tests. The comment criticized the use of

the words ``noninvasive testing'' as being overly broad.

FDA disagrees with this comment. FDA believes that the limitations

are necessary to assure that devices are not marketed that are

significantly different from the devices exempted from premarket

notification, particularly in the area of IVD's where devices are often

subject to changes in intended use and conditions of use. Noninvasive

testing devices should not be exempt because they almost always involve

novel matrices and novel technologies. However, FDA is clarifying the

phrase, ``noninvasive testing,'' by citing the definition of

``noninvasive'' found in Sec. 812.3(k) in the proposed limitations on

exemptions.

14. One comment suggested that FDA should review the exemptions and

reservations in existing classifications to assure that the present

lists are consistent with those listed in the February 2, 1998, notice.

FDA has reviewed the existing regulations again and is proposing to

reserve five currently exempted device classifications (Secs. 862.3750,

862.3850, 870.4200, 886.4750, and 890.1175).

15. One comment suggested that FDA reserve 11 class I devices that

FDA stated it considered exempt class I devices in the February 2,

1998, Federal Register notice and subject them to section 510(k) of the

act requirements, including: Cultured animal and human cells (21 CFR

864.2280); Microorganism differentiation and identification device (21

CFR 866.2660); Coxsackievirus serological reagents (21 CFR 866.3145);

Echinococcus spp. serological reagents (21 CFR 866.3200); Equine

encephalomyelitis virus serological reagents (21 CFR 866.3240);

Lymphocytic choriomeningitis virus serological reagents (21 CFR

866.3360); Mumps virus serological reagents (21 CFR 866.3380);

Poliovirus serological reagents (21 CFR 866.3405); Trichinella spiralis

serological reagents (21 CFR 866.3850); Rickettsia serological reagents

(21 CFR 866.3500); and Streptococcus spp. serological reagents (21 CFR

866.3740).

FDA does not agree with the comment that these devices meet the

reserved criteria. FDA notes the limitations on exemptions are

specifically designed to maintain premarket review for devices used in

``screening, diagnosis, or monitoring life threatening diseases'' or

``to infer the identity of a microorganism directly from clinical

material.'' While section 510(k) of the act exemptions would apply to

devices marketed for uses the agency would consider lower risk, such as

determination of immune status or for epidemiological uses of these

devices, they would not apply to devices with diagnostic claims for use

in life-threatening disease states or for direct detection of a

microorganism using clinical material. Therefore, FDA is proposing to

designate these 11 devices as exempt from section 510(k) of the act

requirements subject to the limitations on exemptions.

16. One comment suggested that the limitations on exemptions are

unnecessary, confusing, and difficult to apply, especially to IVD's.

This comment additionally notes ``we question the basis for FDA's broad

restrictions in such a specific category of devices.''

FDA does not agree that the language is unnecessary, confusing, or

difficult to apply. The limitations language that was in the February

2, 1998, Federal Register notice, and that is proposed for all class I

devices modifies the limitations on exemptions currently found in

Sec. ______.9 of each device classification regulation part (e.g.,

Secs. 862.9, 864.9, etc.) only in three ways. First, FDA has referenced

class II devices to reflect that both class I and class II devices may

be exempted in accordance with new section 510(l) and (m). Second, the

limitations language modifies current limitations language by stating

that devices are to be compared to ``any legally marketed device in

that generic type of device'' rather than a device on the market

``before May 28, 1976'' or a ``preamendments device to which it has

been determined substantially equivalent.'' Third, the limitations

language adds specific language relating to IVD's. The agency cannot

predict all possible different intended uses or changes in fundamental

scientific technologies that may significantly affect safety and

effectiveness; limitations on exemptions are, therefore, in the best

interest of the public health because they ensure that devices

incorporating such changes will be reviewed for safety and

effectiveness by the agency before they go to market.

In order to efficiently allocate review resources, the agency has

developed a risk-based approach toward use of the limitations on

exemptions to ensure that high-risk devices remain subject to premarket

review. The limitations on exemptions continue to take into account two

critical risk elements--intended use and novelty of technology.

Furthermore, FDA believes that in vitro diagnostic devices are

unique because their safety and effectiveness relates primarily to the

information generated by these devices rather than the direct

interaction between device and patient. FDA has more fully discussed

the need for these limitations earlier in this document.

17. One comment believed the limitations on exemptions required

clarification as follows:

With regard to the first limitation (``has an intended use that

is different from the intended use of a legally marketed device in

that generic type''), we believe that current law is clear that if a

device has an intended use different than that expressed in the

definition contained in the Code of Federal Regulations (CFR), such

device would not be the same as the exempted device. The exemption

would simply not apply to that device. However, ``intended use'' can

encompass many different concepts that go beyond the general

intended use statements that comprised the CFR definitions. There

has been some controversy, for instance, over the extent to which

indications for use can change intended use. Our position is that

any indication for use that has been included in a previous 510(k)

order of classification identifies the scope of the intended use for

each exempt type of device. Minor variances of indications for use

within the intended use of an exempt type of device should have no

effect on the status of a 510(k) exemption.

FDA has interpreted Sec. ______.9(a) in the limitations on

exemptions under the current regulations to mean that any legally

marketed device (as defined in 21 CFR 807.92(a)(3)) within a device

classification regulation may serve as a predicate for another

manufacturer's device and the other manufacturer's device may be

exempt. FDA believes that any additional indication for use for an

exempt classification device type (i.e., an indication not previously

cleared) is considered a different intended use and does not meet the

limitations on exemptions, and therefore, requires a new premarket

notification. FDA agrees that minor variances in indications would not

affect the exemption status of the classification. FDA notes that in

its guidance entitled ``Deciding When to Submit a 510(k) for a Change

to an Existing Device,'' FDA states, in regard to minor variances in

indications of closely related populations, ``If the expansion is to a

population with similar demographics, diagnosis, prognosis, comorbidity

and potential for complications as the original, then a new 510(k) is

not ordinarily expected.''

[[Page 63227]]

18. On its own initiative, FDA is proposing to require premarket

notification for five devices that are currently exempt from premarket

notification: Quinine test system (Sec. 862.3750), sulfonamide test

system (Sec. 862.3850), cardiopulmonary bypass accessory equipment

(Sec. 870.4200), electrode cable (Sec. 890.1175), and ophthalmic eye

shield (when made of other than plastic or aluminum) (Sec. 886.4750).

IV. FDA Proposal to Revoke Exemptions

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

(Sec. 862.3850)

On June 8, 1988 (53 FR 21447), FDA published a final rule exempting

the quinine test system and the sulfonamide test system from premarket

notification requirements. FDA stated that it was exempting these

products because it believed that premarket notification was not

necessary to protect the public health.

The quinine test system is used to measure quinine, a fever-

reducing and pain-relieving drug used to treat malaria, in the serum or

urine. Measurements obtained by this device are used in the diagnosis

and treatment of quinine overdose and malaria. If this device fails,

persons who have malaria may suffer serious life-threatening

consequences by not receiving the appropriate amount of quinine.

Similarly, the sulfonamide test system is intended to measure

sulfonamide levels which are used to treat life-threatening bacterial

infections. The failure of this device may also result in the improper

treatment of a life-threatening disease.

Given that these devices are used in determining the treatments for

life-threatening diseases, and an inaccurate measurement of the

treatment drug could result in life-threatening consequences, FDA does

not believe that its previous determinations to exempt these devices

from premarket notification were correct. Accordingly, FDA believes

that premarket review is necessary to assure the safety and

effectiveness of these devices. Moreover, FDA believes that these

products meet the reserved criteria for premarket review under section

510(l), in that they are intended for a use which is of substantial

importance in preventing impairment of human health, and present a

potential unreasonable risk of illness or injury. Therefore, FDA is

proposing to require manufacturers of these products to submit

premarket notifications.

B. Ophthalmic Eye Shields (Sec. 886.4750)

On September 2, 1987 (52 FR 33366), FDA published a final rule

classifying ophthalmic eye shields as class I devices. This generic

type of device is described in Sec. 886.4750 as ``a device that

consists of a plastic or aluminum eye covering intended to protect the

eye or retain dressing materials in place.'' Plastic or aluminum eye

shields rest over the forehead and cheek and do not contact the eye.

Since that classification, FDA has found eye shields that are made

of collagen substantially equivalent to eye shields made out of plastic

or aluminum in Sec. 886.4750. Collagen eye shields, unlike aluminum and

plastic eye shields, come in direct contact with the cornea and are

indicated for relief of discomfort from post-surgical, traumatic and

nontraumatic corneal conditions. Unlike aluminum and plastic eye

shields, there are toxicological concerns relating to biocompatibility

and dissolving time for collagen materials. In premarket reviews, FDA

has examined biocompatibility and dissolving issues in determining the

substantial equivalence of collagen eye shields to plastic and aluminum

eye shields.

On December 7, 1994 (59 FR 63005), FDA published a final rule

exempting this classification from premarket notification requirements,

and quality systems requirements, except 21 CFR 820.198, with respect

to complaint files. FDA erred in not amending the codified language at

that time to retain premarket review and quality system requirements

for collagen eye shields that had been placed in that classification.

Despite the exemption language, FDA has continued to receive and review

premarket notifications for eye shields made out of collagen.

Because the toxicological issues cause the product to meet the

reserved criteria in that the devices are intended for a use which is

of substantial importance in preventing impairment of human health or

present a potential unreasonable risk of illness or injury, FDA is

proposing to amend the codified text to state that collagen eye shields

are not exempt from premarket notification requirements.

C. Cardiopulmonary Bypass Accessory Equipment (Sec. 870.4200) and

Electrode Cable (Sec. 890.1175)

On June 12, 1989 (54 FR 25042), FDA published a final rule

exempting electrode cables (Sec. 890.1175) and cardiopulmonary bypass

accessory equipment (Sec. 870.4200) from premarket notification

requirements. FDA received numerous reports of deaths and injuries

associated with unprotected patient cables and lead wires. To address

the risk of patient exposure to macro shock or electrocution due to the

inappropriate connection of a patient connected cable or electrode lead

wire to an alternating current power source, in the Federal Register of

May 9, 1997 (62 FR 25477), FDA published a final rule establishing a

performance standard for cables and leads. In the preamble of that

final rule, FDA announced that it intended to reclassify electrode

cables (Sec. 890.1175) and cardiopulmonary bypass accessory equipment

(Sec. 870.4200) to class II to subject them to this performance

standard. In the meantime, FDA is proposing to subject these devices to

premarket review to assure that they are safe and effective, pending

the rulemaking to reclassify them into class II.

V. Proposed Designation of Devices

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

issued a notice of its intent to propose to exempt a list of class I

(general controls) devices from the requirement of premarket

notification, subject to the limitations of exemptions. FDA has

reviewed that list and other devices in light of the comments received

in response to the February 2, 1998, notice and other information that

has come to FDA's attention. As a result, FDA is proposing to designate

as exempt certain devices that were not listed as exempt in the

February 2, 1998, notice and to designate as reserved devices certain

devices that were not designated as reserved in the February 2, 1998,

notice or that were previously exempted by regulation.

The following devices are devices that FDA believes meet the

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

proposing to designate that they remain subject to premarket

notification under new section 510(l) added to the act:

[[Page 63228]]

Table 1.--Proposed Designations of Reserved Class I Devices

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

21 CFR Section Name of Device

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

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 system2

864.9195 Blood mixing devices and blood weighing devices2

866.2390 Transport culture medium

866.2560 Microbial growth monitor3

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

870.4200 Cardiopulmonary bypass accessory equipment

872.3700 Dental mercury

872.4200 Dental handpiece and accessories

872.6250 Dental chair and accessories4

872.6640 Dental operative unit and accessories5

872.6710 Boiling water sterilizer

876.5160 Urological clamps for males6

878.4460 Surgeon's glove

880.5090 Liquid bandage7

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 cannula8

882.4545 Shunt system implantation instrument9

884.2980(a) Telethermographic system10

884.2982(a) Liquid crystal thermographic system11

884.5435 Unscented menstrual pads (intralabial pads and reusable

menstrual pads)

886.4070 Powered corneal burr12

886.4300 Intraocular lens guide13

886.4370 Keratome

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

aluminum)

888.1500 Goniometer

890.1175 Electrode cable

890.3850 Mechanical wheelchair

890.5710 Hot or cold disposable pack14

892.1100 Scintillation (gamma) camera

892.1110 Positron camera

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

\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.

[[Page 63229]]

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

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

\11\ Meets reserved criteria if nonelectrically powered and 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 and injectors for soft or foldable intraocular lenses (IOL's).

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

FDA is proposing to amend the regulations to designate the

following devices as exempt from premarket notification because FDA

believes that they do not meet the reserved criteria under section 206

of the FDAMA that adds new section 510(l) of the act:

Table 2.--Proposed Designations of Exempted Class I Devices

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

21 CFR Section Name of Device

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

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

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

[[Page 63230]]

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

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

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 system2

864.9185 Blood grouping view box

864.9195 Blood mixing devices and blood weighing devices2

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 system3

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

[[Page 63231]]

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 system4

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 pad5

872.6300 Rubber dam6

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 aid6

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 males7

876.5210 Enema kit

876.5250(b)(2) Urine collector and accessories8

876.5980(b)(2) Gastrointestinal tube and accessories9

878.3250 External facial fracture fixation appliance

878.3910 Noninflatable extremity splint

878.3925 Plastic surgery kit and accessories

878.4040 Surgical apparel10

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 bandage11

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 cannula12

882.4545 Shunt system implantation instrument13

882.4650 Neurosurgical suture needle

882.4750 Skull punch14

884.1040 Viscometer for cervical mucus

886.1780 Retinoscope15

886.1940 Tonometer sterilizer

886.4070 Powered corneal burr16

886.4300 Intraocular lens guide17

886.5850 Sunglasses (nonprescription

890.5180 Manual patient rotation bed

890.5710 Hot or cold disposable pack18

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

[[Page 63232]]

892.1970 Radiographic ECG/respirator, synchronizer

892.2010 Medical image storage device

892.2020 Medical image communication 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 Sec. 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 Sec.

876.5980(b)(2) (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.

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

VI. Differences Between the February 2, 1998, List of Exempt and

Reserved Devices, and List of Exempt and Reserved Devices Proposed

Herein

As stated previously, FDA issued a notice on February 2, 1998, in

the Federal Register that listed the devices that it considered exempt

from 510(k) requirements (exempt), and those it considered subject to

510(k) requirements (reserved) under new section 510(l). This document

proposes to designate the reserved and exempt lists by notice and

comment rulemaking. Although most of the device categories listed in

the February 2, 1998, notice, and the device categories listed in this

proposal are identical, there are a few differences. These differences

are described in the following lists:

Table 3.--Proposed Reserved Devices That Are Currently Exempted by Regulation

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

21 CFR Section Name of Device

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

862.3750 Quinine test system

862.3850 Sulfonamide test system

870.4200 Cardiopulmonary bypass accessory equipment

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

aluminum)

890.1175 Electrode cable

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

Table 4.--Additional Proposed Reserved Devices Not Considered Reserved Under the February 2, 1998, Federal

Register Notice

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

21 CFR Section Name of Device

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

862.3050 Breath alcohol test system

872.3700 Dental Mercury

884.5435 Unscented menstrual pads (intralabial pads and reusable

menstrual pads)

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

Table 5.--Additional Proposed Exempted Devices Not Considered Exempted in the February 2, 1998, Federal Register

Notice

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

21 CFR Section Name of Device

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

864.3250 Specimen transport and storage container (OTC)

864.6150 Capillary blood collection tube

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

872.3540(b)(1) OTC dental cushion or pad (wax impregnated cotton cloth)

872.6300 Rubber dam

874.1100 Earphone cushion for audiometric testing

874.3540 Prosthesis modification instrument for ossicular replacement

surgery

874.4420 Ear, nose, and throat manual surgical instrument

876.5980(b)(2) Gastrointestinal tube and accessories (dissolvable nasogastric

feed tube guide for the nasogastric tube)

[[Page 63233]]

878.3250 External facial fracture appliance

878.3910 Noninflatable extremity splint

878.3925 Plastic surgery kit and accessories

878.4100 Organ bag

882.1200 Two point discriminator

882.1500 Esthesiometer

882.1750 Pinwheel

892.1350 Nuclear scanning bed

892.2010 Medical image storage device

892.2020 Medical image communication device

892.6500 Personnel protective shield

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

VII. Environmental Impact

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

actions are of a type that do not individually or cumudatave a

significant effect on the human environment. Therefore, neither an

environmental assessment nor an environmental impact statement is

required.

VIII. Analysis of Impacts

FDA has examined the impacts of the proposed 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 (Pub. L. 104-121), and the Unfunded Mandates Reform Act of 1995

(Pub. L. 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 proposed rule is consistent with

the regulatory philosophy and principles identified in the Executive

Order. In addition, the proposed 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 proposed rule

would reduce a regulatory burden by exempting manufacturers of devices

subject to the rule from the requirements of premarket notification.

FDA is proposing to require premarket notification for 5 devices

that were previously exempt from premarket notification. These devices

are as follows:

A. Cardiopulmonary Bypass Accessory Equipment (Sec. 870.4200) and

Electrode Cable (Sec. 890.1175).

In the Federal Register of May 9, 1997 (62 FR 25477), FDA

published a final rule to establish a performance standard for

electrode lead wires and patient cables. In the preamble to that rule

(62 FR 25485), FDA noted that three unprotected cable and electrode

lead wire systems are included in class I devices, and, as such, are

not subject to a mandatory performance standard. These include the two

devices listed previously and the AC-powered goniometer (21 CFR

888.1500). FDA further stated that, because of the degree of health

risk, the agency intended to reclassify the devices into class II so

that they would be subject to the mandatory performance standard. The

cardiopulmonary bypass accessory equipment and the electrode cable were

already exempt from premarket notification; the AC-powered goniometer

was not. Because of the degree of health risk, FDA believes that these

devices should be designated as reserved devices.

FDA also included in the preamble of the May 9, 1997, rule an

assessment of the economic impact of imposition of the standard

including an assessment of its effect on small businesses. In this

assessment, FDA included the three class I devices to which the rule

would later apply. FDA concluded that the rule would not have a

significant economic impact on a substantial number of small entities.

This rule would only impose the additional requirement of submitting a

premarket notification for these devices. Because the premarket

notification would consist primarily of a certification of compliance

with the cables and leads standard, FDA believes that this requirement

will not be a significant burden.

B. 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. FDA would be primarily interested in the

biocompatibility of the devices. FDA estimates that preparation of such

a premarket notification would cost no more than $5,000.

C. 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 1

year.

IX. Paperwork Reduction Act of 1995

FDA tentatively concludes that this proposed 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.

X. Comments

Interested persons may, on or before January 26, 1999, submit to

the Dockets Management Branch (address above) written comments

regarding this proposal. Two copies of any comments are to be submitted

except that individuals may submit one copy.

[[Page 63234]]

Comments are to be identified with the docket number found in brackets

in the heading of this document. Received comments may be seen in the

office above between 9 a.m. and 4 p.m., Monday through Friday.

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

Blood, 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, FDA is

proposing to amend 21 CFR parts 862, 864, 866, 868, 870, 872, 874, 876,

878, 880, 882, 884, 886, 888, 890, and 892 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 Food and Drug Administration's (FDA's) decision to grant an

exemption from the requirement of premarket notification (section

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

upon the existing and reasonably foreseeable characteristics of

commercially distributed devices within that generic type or, in the

case of in vitro diagnostic devices, for which a misdiagnosis as a

result of using the device would not be associated with high morbidity

or mortality. Because FDA cannot anticipate every change in intended

use or characteristic that could significantly affect a device's safety

or effectiveness, 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 and 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) 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;

(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.

* * * * *

[[Page 63235]]

(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.

* * * * *

(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

[[Page 63236]]

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 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

[[Page 63237]]

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.

* * * * *

(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.

[[Page 63238]]

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 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.

* * * * *

[[Page 63239]]

(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:

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 Food and Drug Administration's (FDA's) decision to grant an

exemption from the requirement of premarket notification (section

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

upon the existing and reasonably foreseeable characteristics of

commercially distributed devices within that generic type or, in the

case of in vitro diagnostic devices, for which a misdiagnosis as a

result of using the device would not be associated with high morbidity

or mortality. Because FDA cannot anticipate every change in intended

use or characteristic that could significantly affect a device's safety

or effectiveness, 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 and 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) 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;

(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

[[Page 63240]]

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:

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 Food and Drug Administration's (FDA's) decision to grant an

exemption from the requirement of premarket notification (section

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

upon the existing and reasonably foreseeable characteristics of

commercially distributed devices within that generic type or, in the

case of in vitro diagnostic devices, for which a misdiagnosis as a

result of using the device would not be associated with high morbidity

or mortality. Because FDA cannot anticipate every change in intended

use or characteristic that could significantly affect a device's safety

or effectiveness, 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 and 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) 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;

(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

[[Page 63241]]

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:

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:

[[Page 63242]]

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:

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 Food and Drug Administration's (FDA's) decision to grant an

exemption from the requirement of premarket notification (section

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

upon the existing and reasonably foreseeable characteristics of

commercially distributed devices within that generic type or, in the

case of in vitro diagnostic devices, for which a misdiagnosis as a

result of using the device would not be associated with high morbidity

or mortality. Because FDA cannot anticipate every change in intended

use or characteristic that could significantly affect a device's safety

or effectiveness, 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

[[Page 63243]]

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 and 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) 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;

(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 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 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.

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 Food and Drug Administration's (FDA's) decision to grant an

exemption from the requirement of premarket notification (section

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

upon the existing and reasonably foreseeable characteristics of

commercially distributed devices within that generic type or, in the

case of in vitro diagnostic devices, for which a misdiagnosis as a

result of using the device would not be associated with high morbidity

or mortality. Because FDA cannot anticipate every change in intended

use or characteristic that could significantly affect a device's safety

or effectiveness, 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 and 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) 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;

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

chapter; and

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

158. Section 870.4200 is amended by revising paragraph (b) to read

as follows:

[[Page 63244]]

Sec. 870.4200 Cardiopulmonary bypass accessory equipment.

* * * * *

(b) Classification. Class I.

PART 872--DENTAL DEVICES

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

as follows:

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

160. 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 Food and Drug Administration's (FDA's) decision to grant an

exemption from the requirement of premarket notification (section

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

upon the existing and reasonably foreseeable characteristics of

commercially distributed devices within that generic type or, in the

case of in vitro diagnostic devices, for which a misdiagnosis as a

result of using the device would not be associated with high morbidity

or mortality. Because FDA cannot anticipate every change in intended

use or characteristic that could significantly affect a device's safety

or effectiveness, 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 and 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) 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;

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

chapter; and

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

161. 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.

* * * * *

162. 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.

* * * * *

163. 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.

* * * * *

164. Section 872.6300 is amended by revising paragraph (b) to read

as follows:

Sec. 872.6300 Rubber dam 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. 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.

165. 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.

166. 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

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

as follows:

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

168. 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 Food and Drug Administration's (FDA's) decision to grant an

exemption from the requirement of premarket notification (section

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

upon the existing and reasonably foreseeable characteristics of

commercially distributed devices within

[[Page 63245]]

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

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

associated with high morbidity or mortality. Because FDA cannot

anticipate every change in intended use or characteristic that could

significantly affect a device's safety or effectiveness, 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 and 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) 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;

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

chapter; and

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

169. 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.

170. 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.

171. Section 874.1500 is amended by revising paragraph (b) to read

as follows:

Sec. 874.1500 Gustometer.

* * * * *

(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.

172. 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.

173. 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.

174. 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.

175. 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.

176. 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.

177. 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.

178. 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.

179. 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

[[Page 63246]]

premarket notification procedures in subpart E of part 807 of this

chapter subject to Sec. 874.9.

180. 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

181. 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.

182. 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 Food and Drug Administration's (FDA's) decision to grant an

exemption from the requirement of premarket notification (section

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

upon the existing and reasonably foreseeable characteristics of

commercially distributed devices within that generic type or, in the

case of in vitro diagnostic devices, for which a misdiagnosis as a

result of using the device would not be associated with high morbidity

or mortality. Because FDA cannot anticipate every change in intended

use or characteristic that could significantly affect a device's safety

or effectiveness, 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 and 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, tubercu

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