Medical Devices; Exemptions From Premarket Notification; Class II Devices

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 98N-0015]

Medical Devices; Exemptions From Premarket Notification; Class II

Devices

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 II (special controls) devices, subject to certain limitations,

that are now exempt from the premarket notification requirements under

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

FDA believes that these exemptions will relieve manufacturers from the

need to submit premarket notification submissions for these devices and

will enable FDA to redirect the resources that would be spent on

reviewing such submissions to more significant public health issues.

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

DATES: Effective January 21, 1998. Comments on this notice should be

submitted within 90 days of publication. The agency will review any

comments submitted within the 90-day comment period and will consider

whether the list of class II devices that are exempt from the premarket

notification requirements should be modified.

ADDRESSES: Submit written comments on this notice 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 Federal Food, Drug, and Cosmetic Act (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 the Safe Medical Devices Act of 1990 (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 assure 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, 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), 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.

Section

[[Page 3143]]

206 of the FDAMA, in part, added a new section 510(m) to the act.

Section 510(m)(1) of the act requires FDA, within 60 days after

enactment of the FDAMA, to publish in the Federal Register a list of

each type of class II device that does not require a report under

section 510(k) of the act (generally referred to as a premarket

notification or ``510(k)'') to provide reasonable assurance of safety

and effectiveness. Section 510(m) of the act further provides that a

510(k) will no longer be required for these devices upon the date of

publication of the list in the Federal Register.

Section 510(m)(2) of the act provides that, 1 day after date of

publication of the list under section 510(m)(1), FDA may exempt a

device on its own initiative or upon petition of an interested person,

if FDA determines that a 510(k) is not necessary to provide reasonable

assurance of the safety and effectiveness of the device. This section

requires FDA to publish in the Federal Register a notice of intent to

exempt a device, or of the petition, and to provide a 30-day comment

period. Within 120 days of publication of this document, FDA must

publish in the Federal Register its final determination. If FDA fails

to respond to a petition under this section within 180 days of

receiving it, the petition shall be deemed granted.

II. Criteria for Exemption

In considering whether to exempt class II devices from premarket

notification, FDA focused on whether premarket notification for the

type of device is necessary to provide reasonable assurance of safety

and effectiveness of the device. FDA considered the following factors:

(1) The device does not have a significant history of false or

misleading claims or of risks associated with inherent characteristics

of the device, such as device design or materials (when making these

determinations, FDA has considered the risks associated with false or

misleading claims, and the frequency, persistence, cause or seriousness

of the inherent risks of the device); (2) characteristics of the device

necessary for its safe and effective performance are well established;

(3) changes in the device that could affect safety and effectiveness

will either: (a) Be readily detectable by users by visual examination

or other means such as routine testing, before causing harm, e.g.,

testing of a clinical laboratory reagent with positive and negative

controls; or (b) not materially increase the risk of injury, incorrect

diagnosis, or ineffective treatment; and (4) any changes to the device

would not be likely to result in a change in the device's

classification.

FDA also considered that even when exempting devices, these devices

would still be subject to the limitations on exemptions, as described

in section III of this document.

III. Limitations on Exemptions

The exemption from the requirement of premarket notification for a

generic type of device listed in this document applies only to those

devices that 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. Accordingly, a class II device listed in this document is

not exempt if such 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 an

in-vitro device: That is intended for use in the diagnosis, monitoring

or screening of neoplastic diseases with the exception of

immunohistochemical devices; is intended for use in screening or

diagnosis of familial and acquired genetic disorders, including inborn

errors of metabolism; is intended for measuring an analyte which 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; is intended to assess the risk of

cardiovascular diseases; is intended for use in diabetes management; is

intended to identify or infer the identity of a microorganism directly

from clinical material; is intended 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; is intended for near-patient testing (point

of care).

Class II devices incorporating such changes or modifications are

not exempt from premarket notification because FDA has determined that

premarket notification is necessary to assure the safety and

effectiveness of the device.

In addition to the general limitation on exemptions that applies to

all class II devices that are described previously, FDA may limit the

exemption from premarket notification requirements to certain devices

within a generic class. For example, FDA, in section IV of this

document, is listing the exemption of the biofeedback device, but

limits the exemption to prescription battery powered devices that are

indicated for relaxation training and muscle reeducation. All other

biofeedback devices are still subject to premarket notification

requirements because FDA determined that premarket notification was

necessary to provide a reasonable assurance of safety and effectiveness

for these devices.

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. Indeed, FDA's

determination that premarket notification was unnecessary to provide a

reasonable assurance of safety and effectiveness for devices listed in

this document is based, in part, on the assurance of safety and

effectiveness that other regulatory controls, such as current good

manufacturing practice requirements, provide.

Persons with pending 510(k) submissions for devices that are

exempted in this document, subject to the limitations on exemptions,

should withdraw their submissions.

IV. List of Class II Devices Exempted

FDA is identifying the following devices as class II devices that,

as of the date of publication of this document, are exempt from the

requirement to submit a premarket notification under section 510(k) of

the act, subject to limitations on exemptions in this document:

[[Page 3144]]

Table 1.--Exempted Class II Devices

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21 CFR Sections Name of Devices

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862.1440.............. Lactate dehydrogenase test system

862.1635.............. Total protein test system

864.6100.............. Bleeding time device

864.6400.............. Hematocrit measuring device

864.9160.............. Blood group substances of nonhuman origin for in vitro diagnostic use

864.9550.............. Lectins and protectins

864.9575.............. Environmental chamber for storage of platelet concentrate

864.9600.............. Potentiating media for in vitro diagnostic use

864.9700.............. Blood storage refrigerator and blood storage freezer

866.3060.............. Blastomyces dermatitidis serological reagents

866.3085.............. Brucella spp. serological reagents

866.3135.............. Coccidioides immitis serological reagents

866.3165.............. Cryptococcus neoformans serological reagents

866.3220.............. Entamoeba histolytica serological reagents

866.3280.............. Francisella tularensis serological reagents

866.3300.............. Haemophilus spp. serological reagents

866.3320.............. Histoplasma capsulatum serological reagents

866.3350.............. Leptospira spp. serological reagents

866.3415.............. Pseudomonas spp. serological reagents

866.3460.............. Rabiesvirus immunofluorescent reagents

866.3550.............. Salmonella spp. serological reagents

866.3660.............. Shigella spp. serological reagents

866.3930.............. Vibrio cholerae serological reagents

866.5040.............. Albumin immunological test system

866.5210.............. Ceruloplasmin immunological test system

866.5320.............. Properdin factor B immunological test system

866.5380.............. Free secretory component immunological test system

866.5460.............. Haptoglobin immunological test system

866.5470.............. Hemoglobin immunological test system

866.5490.............. Hemopexin immunological test system

876.1620.............. Urodynamics measurement system

876.1800.............. Urinev flow or volume measuring system

876.2040.............. Enuresis alarm

876.4370.............. Gastroenterlogy-urology evacuator

876.4650.............. Water jet renal stone dislodger system

876.4680.............. Uretal stone dislodger

876.4890(b)(1)........ Urological table and accessories

876.5250(b)(1)........ Urine collector and accessories

880.2200.............. Liquid crystal forehead temperature strip

880.2920.............. Clinical mercury thermometer

880.5100.............. AC-powered adjustable hospital bed

880.5140.............. Pediatric hospital bed

880.5475.............. Jet lavage

880.5500.............. AC-powered patient lift

880.5550.............. Alternating pressure air flotation mattress

880.6740.............. Vacuum-powered body fluid suction apparatus

880.6775.............. Powered patient transfer device

880.6910.............. Wheeled stretcher

882.5050.............. Biofeedback device1

886.3100.............. Ophthalmic tantalum clip

886.3130.............. Ophthalmic conformer

886.3800.............. Scleral shell

890.1925.............. Isokinetic testing and evaluation system

890.3500.............. External assembled lower limb prosthesis

890.3710.............. Powered communication system

890.3725.............. Powered environmental control system

890.5160.............. Air-fluidized bed

890.5170.............. Powered flotation therapy bed

890.5225.............. Powered patient rotation bed

890.5720.............. Water circulating hot or cold pack

890.5740.............. Powered heating pad

892.1980.............. Radiologic table

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\1\ Exemption is limited to prescription battery powered devices that are indicated for relaxation training and

muscle reeducation and prescription use.

V. Additional Exemptions

Under section 510(m)(2) of the act, as described previously,

interested persons may request that FDA exempt any class II device from

the premarket notification requirements. The request should identify

the generic type of device by the CFR section number (e.g., 21 CFR

884.1234) and state clearly why the submitter believes the factors

described in section II of this document apply, and that premarket

notification requirements

[[Page 3145]]

are not necessary to provide reasonable assurance of the safety and

effectiveness of the device. By February 19, 1998, FDA will provide

guidance on how to request such an exemption.

Dated: January 15, 1998.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 98-1485 Filed 1-16-98; 12:00 pm]

BILLING CODE 4160-01-F