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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 98N-0009]

Medical Devices; Exemptions From Premarket Notification and

Reserved Devices; Class I

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is publishing a list of

class I devices, subject to certain limitations, that will be exempt

from premarket notification requirements on February 19, 1998. FDA is

also publishing a list of those class I devices that FDA believes will

remain subject to premarket notification requirements because they meet

the new statutory criteria for premarket notification requirements.

These lists do not include class I devices that have been previously

exempted by regulation from the premarket notification requirements.

FDA is taking this action in order to meet a requirement of the Food

and Drug Administration Modernization Act of 1997 (the FDAMA). The

agency requests comments on whether the list of class I devices that

will remain subject to the premarket notification requirements should

be modified.

DATES: This notice is effective February 19, 1998. Submit written

comments by May 4, 1998.

ADDRESSES: Submit written comments to the Dockets Management Branch

(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,

Rockville, MD 20857.

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

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

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

1190.

SUPPLEMENTARY INFORMATION:

I. Statutory Background

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

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

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

of regulation necessary to provide a reasonable assurance of safety and

effectiveness. Under the Medical Device Amendments of 1976 (the 1976

amendments) (Pub. L. 94-295), as amended by the Safe Medical Devices

Act of 1990 (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

[[Page 5388]]

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

implementing regulations, 21 CFR part 807, require persons who intend

to market a new device to submit a premarket notification report

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, section 513(i)

of the act. On November 21, 1997, the President signed into law the

FDAMA (Pub. L. 105-115). Section 206 of the FDAMA, in part, added a new

section 510(l) to the act. Under section 501 of the FDAMA, new section

510(l) of the act becomes 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 (hereafter ``reserved

criteria''). Based on these reserved criteria, 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, e.g., devices with rapidly evolving

technology or expansions of intended uses. The agency considered the

history of adverse event reports under the medical device reporting

program for these devices, as well as their history of product recalls.

Given the inherent risks with the devices listed and/or the disease or

condition 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 this notice, FDA

is publishing two lists of devices: (1) A list of the class I devices

that FDA believes will be exempt from the premarket notification

requirements on February 19, 1998, under section 510(l) of the act,

subject to certain limitations from the premarket notification

requirements described herein; and (2) a list of the devices that FDA

believes fit the reserved criteria under section 510(l) of the act and,

therefore, will continue to be subject to premarket notification

requirements. These lists do not include class I devices that have been

previously exempted by regulation from the premarket notification

requirements. FDA believes that class I devices that have previously

been exempted generally do not fall within the reserved criteria under

section 510(l) of the act. When FDA issues a proposed rule to amend the

regulations to codify class I devices that remain subject to the

premarket notification requirements, FDA, in limited cases, may propose

to revoke the exemption from the premarket notification requirements

based on the reserved criteria of section 510(l) of the act.

II. Limitations on Exemptions

As stated previously, 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, 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 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 type present a potential

unreasonable risk of illness or injury because their safety and

effectiveness characteristics are unknown. Moreover, FDA believes that

in vitro diagnostic devices 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 above fit within the reserved criteria under

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

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

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

marketed device in that generic type; e.g., the device is intended for

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

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

different fundamental scientific technology than that used by a legally

marketed device in that generic type, 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 a deoxyribonucleic acid (DNA) probe or nucleic acid

hybridization or amplification technology rather than culture or

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

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

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

in screening or diagnosis of familial and acquired genetic disorders,

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

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

monitoring life threatening diseases such as acquired immune deficiency

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

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

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

identify or infer the identity of a microorganism directly from

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

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

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

intended for use in matrices other than serum or plasma; uses

noninvasive testing; and (h) for near patient testing (point of care).

Class I devices incorporating such changes or modifications are not

exempt from premarket notification because FDA believes they meet the

reserved criteria described above, under 510(l).

In addition to the general limitation on exemptions that FDA

considers applicable to all class I devices that is described above,

FDA also considers certain devices within a generic class to remain

subject to the premarket notification requirements because they

[[Page 5389]]

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, FDA, elsewhere in

this document, 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 advises additionally 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. Lists of Devices

The following devices are devices that FDA believes meet the

reserved criteria in section 206 of the FDAMA and, therefore, would

remain subject to premarket notification under new section 510(l) added

to the act:

Table 1.--Reserved Class I Devices

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21 CFR Section Name of Device

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862.1065.............. Ammonia test system

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

862.1410.............. 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

862.1775.............. Uric acid test system

862.3110.............. Antimony test system

862.3120.............. Arsenic test system

862.3220.............. Carbon monoxide test system

862.3240.............. Cholinesterase test system

862.3600.............. Mercury test system

864.7040.............. Adenosine triphosphate release assay

864.8950.............. Russell viper venom reagent

864.9050.............. Blood bank supplies

864.9125.............. Vacuum-assisted blood collection system

864.9195.............. Blood mixing devices and blood weighing devices\2\

866.2390.............. Transport culture medium

866.2560.............. Microbial growth monitor\3\

866.2850.............. Automated zone reader

866.2900.............. Microbiological specimen collection and transport device

866.3110.............. Campylobacter fetus serological reagents

866.3120.............. Chlamydia serological reagents

866.3235.............. Epstein-Barr virus serological reagents

866.3370.............. Mycobacterium tuberculosis immunofluorescent reagents

866.3870.............. Trypanosoma spp. serological reagents

872.4200.............. Dental handpiece and accessories

872.6250.............. Dental chair and accessories\4\

872.6640.............. Dental operative unit and accessories\5\

872.6710.............. Boiling water sterilizer

876.5160.............. Urological clamps for males\6\

878.4460.............. Surgeon's glove

880.5090.............. Liquid bandage\7\

880.5680.............. Pediatric position holder

880.6250.............. Patient examination glove

880.6375.............. Patient lubricant

880.6760.............. Protective restraint

882.1030.............. Ataxiagraph

882.1420.............. Electroencephalogram (EEG) signal spectrum analyzer

882.4060.............. Ventricular cannula\8\

882.4545.............. Shunt system implantation instrument\9\

884.2980(a)........... Telethermographic system\10\

884.2982(a)........... Liquid crystal thermographic system\11\

886.4070.............. Powered corneal burr\12\

886.4300.............. Intraocular lens guide\13\

886.4370.............. Keratome

888.1500.............. Goniometer

890.3850.............. Mechanical wheelchair

890.5710.............. Hot or cold disposable packs\14\

892.1100.............. Scintillation (gamma) camera

892.1110.............. Positron camera

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\1\ Meets reserved criteria when assayed and 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 the accessory tray to the unit.

[[Page 5390]]

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

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

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

\9\ Meets reserved criteria if not made of surgical 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 IOL's.

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

The following devices are devices that FDA believes do not meet the

reserved criteria under section 206 of the FDAMA and, therefore, will

be exempt from premarket notification as of February 19, 1998, under

new section 510(l) added to the act:

Table 2.--Exempted Class I Devices

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21 CFR Section Name of Device

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

862.1040.............. Aldolase test system

862.1060.............. Delta-aminolevulinic acid test system

862.1075.............. Androstenedione test system

862.1080.............. Androsterone test system

862.1095.............. Ascorbic acid test system

862.1115.............. Urinary bilirubin and its conjugates (nonquantitative) test system

862.1130.............. Blood volume test system

862.1135.............. C-peptides of proinsulin test system

862.1165.............. Catecholamines (total) test system

862.1175.............. Cholesterol (total) test system

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.............. Estrogen (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

862.1310.............. Galactose 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 sytem

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

[[Page 5391]]

862.1610.............. Prenanetriol test system

862.1615.............. Pregnenolone test system

862.1620.............. Progesterone test system

862.1625.............. Prolactin (lactogen) test system

862.1630.............. Protein (fractionation) test system

862.1645.............. Urinary protein or albumin (nonquantitative) test system

862.1650.............. Pyruvate kinase test system

862.1655.............. Pyruvic acid test system

862.1660.............. Quality control material (assayed and unassayed)\1\

862.1705.............. Triglyceride test system

862.1725.............. Trypsin test system

862.1730.............. Free tyrosine 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 use

862.2900.............. Automated urinalysis system

862.3280.............. Clinical toxicology control material

864.2280.............. Cultured animal and human cells

864.5240.............. Automated blood cell diluting apparatus

864.9185.............. Blood grouping view box

864.9195.............. Blood mixing devices and blood weighing devices\2\

864.9225.............. Cell-freezing apparatus and reagents for in vitro diagnostic use

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

864.9320.............. Copper sulphate solution for specific gravity determination

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 scheneckii 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 system

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

866.5400.............. Alpha-globulin immunological test system

866.5420.............. Alpha-I-glycoproteins immunological test system

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

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

[[Page 5392]]

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

866.5560.............. Lactic dehydrogenase immunological test system

866.5570.............. Lactoferrin immunological test system

866.5590.............. Lipoprotein X immunological test system

866.5715.............. Plasminogen immunological test system

866.5735.............. Prothrombin immunological test system\4\

866.5765.............. Retinol-binding protein immunological test system

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

868.1910.............. Esophageal stethoscope

868.5620.............. Breathing mouthpiece

868.5640.............. Medicinal nonventilatory nebulizer (atomizer)

868.5675.............. Rebreathing device

868.5700.............. Nonpowered oxygen tent

868.6810.............. Tracheobronchial suction catheter

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

874.1070.............. Short increment sensitivity index (SISI) adapter

874.1500.............. Gustometer

874.1800.............. Air or water caloric stimulator

874.1925.............. Toynbee diagnostic tube

874.3300(b)(1)........ Hearing aid\5\

874.4100.............. Epistaxis balloon

874.5300.............. Ear, nose, and throat examination and treatment unit

874.5550.............. Powered nasal irrigator

874.5840.............. Antistammering device

876.5160.............. Urological clamps for males\6\

876.5210.............. Enema kit

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

878.4040.............. Surgical apparel\7\

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 chair and accessories

880.5090.............. Liquid bandage\8\

880.5270.............. Neonatal eye pad

880.5420.............. Pressure infusor for an I.V. bag

882.4060.............. Ventricular cannula\9\

882.4545.............. Shunt system implantation instrument\10\

882.4650.............. Neurosurgical suture needle

882.4750.............. Skull punch\11\

884.1040.............. Viscometer for cervical mucus

886.1350.............. Keratoscope\12\

886.1780.............. Retinoscope\13\

886.1940.............. Tonometer sterilizer

886.4070.............. Powered corneal burr\14\

886.4300.............. Intraocular lens guide\15\

886.5850.............. Sunglasses (nonprescription)

890.5180.............. Manual patient rotation bed

890.5710.............. Hot or cold disposable pack\16\

892.1300.............. Nuclear rectilinear scanner

892.1320.............. Nuclear uptake probe

892.1330.............. Nuclear whole body scanner

892.1410.............. Nuclear electrocardiograph synchronizer

892.1890.............. Radiographic film illuminator

892.1910.............. Radiographic grid

892.1960.............. Radiographic intensifying screen

892.1970.............. Radiographic ECG/respirator, synchronizer

892.5650.............. Manual radionuclide applicator system

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\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 Sec. 864.7290.

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

\5\ Exemption is limited to air-conduction hearing aids.

\6\ Exemption does not include devices for internal use or devices used for females.

\7\ Exemption is limited to class I category other than surgical gowns and surgical masks.

\8\ Exemption is limited to uses as a skin protectant.

\9\ Exemption is limited to surgical grade stainless steel.

\10\ Exemption is limited to devices made of surgical grade stainless steel.

\11\ Exemption should not be confused with Sec. 882.4305.

\12\ Exemption is extended to those with software.

\13\ Exemption is limited to class I battery-powered devices.

\14\ Exemption is limited to rust ring removal.

[[Page 5393]]

\15\ Exemption does not apply if used as folders and injectors for soft or foldable IOL's.

\16\ Exemption does not apply when indicated for infants.

IV. Comments

Interested persons may, on or before May 4, 1998, submit to the

Dockets Management Branch (address above) written comments regarding

the notice. Two copies of any comments are to be submitted, except that

individuals may submit one copy. 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.

Dated: January 23, 1998.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 98-2498 Filed 1-30-98; 8:45 am]

BILLING CODE 4160-01-F