3142 Federal Register / Vol. 63, No. 13 / Wednesday, January 21, 1998 / Notices

collection of information to OMB for

review and clearance.

Exemptions and Variances from the

Performance Standard for Electrode

Lead Wires and Patient Cables

FDA regulations in part 898 (21 CFR

part 898) mandate a performance

standard for electrode lead wires and

patient cables. The purpose of the

performance standard is to prevent

electrocution from the use of

unprotected electrode lead wires and

patient cables with medical devices. To

provide maximum flexibility in

situations where the electrical accidents

can be prevented in other ways, § 898.14

provides that any person subject to the

performance standard may submit a

petition under 21 CFR 10.30 requesting

an exemption or variance from the

standard. The petition must

demonstrate why compliance with the

standard is unnecessary or unfeasible

and what alternate means will be used

to protect the public health. FDA will

use this information to determine

whether granting an exemption is in the

best interests of the public health.

Allowing for exemptions and variances

will provide for flexibility while

assuring public health protection.

Section 898.14 is stayed pending OMB

clearance. FDA will announce the

effective date of § 898.14 in the Federal

Register. Anticipated respondents to

this collection of information are

medical device manufacturers and

distributors, and health care facilities.

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

10.30 50 1 50 10 500

1There are no capital costs or operating maintenance costs associated with this collection of information.

Dated: January 8, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–1294 Filed 1–20–98; 8:45 am]

BILLING CODE 4160–01–F

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.

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 lifesupporting 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
Federal Register / Vol. 63, No. 13 / Wednesday, January 21, 1998 / Notices 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:
3144 Federal Register / Vol. 63, No. 13 / Wednesday, January 21, 1998 / Notices

TABLE 1.—EXEMPTED CLASS II DEVICES

21 CFR Sections Name of Devices

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

1Exemption 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
Federal Register / Vol. 63, No. 13 / Wednesday, January 21, 1998 / Notices 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

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Immunology Devices Panel of the

Medical Devices Advisory Committee;

Notice of Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

This notice announces a forthcoming

meeting of a public advisory committee

of the Food and Drug Administration

(FDA). At least one portion of the

meeting will be closed to the public.

Name of Committee: Immunology

Devices Panel of the Medical Devices

Advisory Committee.

General Function of the Committee:

To provide advice and

recommendations to the agency on FDA

regulatory issues.

Date and Time: The meeting will be

held on February 2, 1998, 9:30 a.m. to

6:30 p.m.

Location: Parklawn Bldg., conference

rooms D & E, 5600 Fishers Lane,

Rockville, MD.

Contact Person: Peter E. Maxim,

Center for Devices and Radiological

Health (HFZ–440), Food and Drug

Administration, 2098 Gaither Rd.,

Rockville, MD 20850, 301–594–1293, or

FDA Advisory Committee Information

Line, 1–800–741–8138 (301–443–0572

in the Washington, DC area), code

12516. Please call the Information Line

for up-to-date information on this

meeting.

Agenda: The committee will discuss

proposed prescription home use

labeling for a unitized bladder cancer

tumor marker assay used to aid in the

detection of bladder cancer recurrence.

Also, the committee will discuss, make

recommendations, and vote on a

premarket approval application for a

free PSA (prostate-specific antigen)

assay. The assay is intended to be used

in men over the age of 50 with a

negative digital rectal examination and

a total serum PSA measurement of 4.0

to 10.0 nanograms/milliliter. The free

PSA/total PSA ratio aids in the

differentiation between benign and

malignant prostate disease.

Procedure: On February 2, 1998, from

10 a.m. to 6:30 p.m., the meeting is open

to the public. Interested persons may

present data, information, or views,

orally or in writing, on issues pending

before the committee. Written

submissions may be made to the contact

person by January 29, 1998. Oral

presentations from the public will be

scheduled between approximately 1

p.m. and 2 p.m. Time allotted for each

presentation may be limited. Those

desiring to make formal oral

presentations should notify the contact

person before January 29, 1998, and

submit a brief statement of the general

nature of the evidence or arguments

they wish to present, the names and

addresses of proposed participants, and

an indication of the approximate time

requested to make their presentation.

Closed Committee Deliberations: On

February 2, 1998, from 9:30 a.m. to 10

a.m., the meeting will be closed to

permit discussion and review of trade

secret and/or confidential information

(5 U.S.C. 552b(c)(4)). FDA staff will

present to the committee confidential

information regarding present or future

issues.

FDA regrets that it was unable to

publish this notice 15 days prior to the

February 2, 1998, Immunology Devices

Panel of the Medical Devices Advisory

Committee meeting. Because the agency

believes there is some urgency to bring

this issue to public discussion and

qualified members of the Immunology

Devices Panel of the Medical Devices

Advisory Committee were available at

this time, the Commissioner concluded

that it was in the public interest to hold

this meeting even if there was not

sufficient time for the customary 15-day

public notice.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: January 15, 1998.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 98–1418 Filed 1–15–98; 3:51 pm]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D–0007]

Draft ‘‘Guidance for Industry: For the

Submission of Chemistry,

Manufacturing and Controls and

Establishment Description Information

for Human Plasma-Derived Biological

Products or Animal Plasma or SerumDerived Products;’’ Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of the draft guidance

document entitled ‘‘Guidance for

Industry: For the Submission of

Chemistry, Manufacturing and Controls

and Establishment Description

Information for Human Plasma-Derived

Biological Products or Animal Plasma or

Serum-Derived Products.’’ The draft

guidance document is intended to assist

applicants in the preparation of the

content and format of the chemistry,

manufacturing, and controls (CMC)

section and the establishment

description section of a biologics license

application (BLA), revised Form FDA

356h for human plasma-derived

biological products, animal plasma, or

serum-derived products. This action is

part of FDA’s continuing effort to

achieve the objectives of the President’s

‘‘Reinventing Government’’ initiatives

and FDA Modernization Act of 1997,

and is intended to reduce unnecessary

burdens for industry without

diminishing public health protection.

DATES: Written comments may be

submitted at any time, however,

comments should be submitted by April

21, 1998, to ensure their adequate

consideration in preparation of the final

document.

ADDRESSES: Submit written requests for

single copies of the draft guidance

entitled ‘‘Guidance for Industry: For the

Submission of Chemistry,

Manufacturing and Controls and

Establishment Description Information

for Human Plasma-Derived Biological

Products or Animal Plasma or SerumDerived Products’’ to the Office of

Communication, Training, and

Manufacturers Assistance (HFM–40),

Center for Biologics Evaluation and

Research, Food and Drug

Administration, 1401 Rockville Pike,

Rockville, MD 20852–1448. Send one

self-addressed adhesive label to assist

that office in processing your requests.