FDA Modernization Act of 1997; Guidance Documents for the Medical Device Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. 98D-0078, 98D-0079, 98D-0080, 98D-0081, 98D-0082, and 98D-

0083]

FDA Modernization Act of 1997; Guidance Documents for the Medical

Device Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the

availability of six guidance documents that represent the Center for

Devices and Radiological Health's (CDRH) initial approach to

implementation of revelant sections of the Food and Drug Administration

Modernization Act of 1997 (FDAMA) (Pub. L. 105-115). Many of the

procedural changes for CDRH that are required by the FDAMA are being

implemented initially through these six guidance documents. Due to the

timing of the required implementation, the use of guidance documents is

the most expeditious way to initially implement the FDAMA. The agency

requests comments on these six guidance documents.

DATES: Submit written comments by May 26, 1998. After the close of the

comment period, written comments may be submitted at any time to Ron

Jans (address below)

ADDRESSES: Submit written comments to the Dockets Management Branch

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

Rockville, MD 20857. Comments should be identified with the docket

number for the appropriate guidance document found in the SUPPLEMENTARY

INFORMATION section. Submit written requests for an IBM PC compatible

diskette containing the documents to the Division of Small

Manufacturers Assistance, Center for Devices and Radiological Health

(HFZ-220), Food and Drug Administration, 1350 Piccard Dr., Rockville,

MD 20850. Send two self-addressed adhesive labels to assist that office

in processing your request, or fax your request to 301-443-8818. See

the SUPPLEMENTARY INFORMATION section for electronic access to the

guidance.

FOR FURTHER INFORMATION CONTACT:

For information on this document contact: Ronald P. Parr, Center for

Devices and Radiological Health (HFZ-220), Food and Drug

Administration, 1350 Piccard Dr., Rockville, MD 20850, 301-443-7491,

ext. 128.

To submit comments after the close of the comment period contact: Ron

Jans, Center for Devices and Radiological Health (HFZ-205), Food and

Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, 301-594-

3744.

SUPPLEMENTARY INFORMATION:

I. Background

The FDAMA was signed by the President on November 21, 1997. Several

of the provisions of FDAMA go into effect 90 days after enactment. CDRH

has issued a guidance document outlining the general approaches FDA

intends to take to implement the highest priority provisions of the new

law. FDA published a notice of availability of this general guidance

(referred to as the ``Day 1 guidance'') in the Federal Register of

February 6, 1998 (63 FR 6193).

The agency is announcing the availability of the following six

guidance documents (each with a separate docket number) that represent

CDRH's initial approach to implementation of the various relevant

sections of the FDAMA:

(1) ``Early Collaboration Meetings Under the FDA Modernization Act

(FDAMA), Guidance for Industry and CDRH Staff, Final Document'' (Docket

Number 98D-0078) (FOD # 310),

(2) ``Guidance on PMA Interactive Procedures for Day-100 Meetings

and Subsequent Deficiencies--for Use by CDRH and Industry'' (Docket

Number 98D-0079) ( FOD # 322),

(3) ``30-Day Notices and 135-day PMA Supplements for Manufacturing

Method or Process Changes, Guidance for Industry and CDRH'' (Docket

Number 98D-0080) (FOD # 795),

(4) ``Determination of Intended Use for 510(k) Devices; Final

Document'' (Docket Number 98D-0081) (FOD # 857),

(5) ``New section 513(f)(2)--Evaluation of Automatic Class III

Designation; Guidance for Industry and

[[Page 9571]]

CDRH Staff'' (Docket Number 98D-0082) (FOD # 199), and

(6) ``Procedures for Class II Device Exemptions from Premarket

Notification, Guidance for Industry and CDRH Staff'' (Docket No. 98D-

0083) (FOD # 159).

These guidance documents represent the agency's current thinking on

CDRH's implementation of the FDAMA. These guidance documents do not

create or confer any rights for or on any person and do not operate to

bind FDA or the public. An alternative approach may be used if such

approach satisfies the applicable statute, regulations, or both. Under

FDA's ``Good Guidance Practices'' policy (62 FR 8961, February 27,

1997), each of these guidance documents is a Level 1 guidance document

that may be implemented immediately because it is the subject of a new

statute. FDA will review the comments received in order to determine

whether to revise or revoke the guidance.

These guidance documents may contain collections of information

that require OMB clearance under the Paperwork Reduction Act of 1995.

FDA will seek such approval and provide an opportunity to comment, as

appropriate.

II. Electronic Access

Persons interested in obtaining a copy of the guidance may also do

so using the World Wide Web (WWW). CDRH maintains an entry on the World

Wide Web for easy access to information including text, graphics, and

files that may be downloaded to a PC with access to the Web. Updated on

a regular basis, the CDRH Home Page includes these guidance documents,

device safety alerts, Federal Register reprints, information on

premarket submissions (including lists of approved applications and

manufacturers' addresses), small manufacturers' assistance, information

on video conferencing and electronic submissions, mammography matters,

and other device-oriented information. The CDRH home page may be

accessed at http://www.fda.gov/cdrh/modact/modern.html.

A text-only version of the CDRH Web site is also available from a

computer or VT-100 compatible terminal by dialing 800-222-0185

(terminal settings are 8/1/N). Once the modem answers, press Enter

several times and then select menu choice 1: FDA BULLETIN BOARD

SERVICE. From there follow instructions for logging in, and at the BBS

TOPICS PAGE, arrow down to the FDA home page (do not select the first

CDRH entry). Then select Medical Devices and Radiological Health. From

there select CENTER FOR DEVICES AND RADIOLOGICAL HEALTH for general

information, or arrow down for specific topics.

In order to receive these guidance documents via your fax machine,

call the CDRH Facts-On-Demand (FOD) system at 800-899-0381 or 301-827-

0111 from a touch-tone telephone. At the first voice prompt press 1 to

access DSMA Facts, at second voice prompt press 2, and then enter the

document number followed by the pound sign (#). The appropriate FOD

number is listed next to the title of the document in the list above.

Then follow the remaining voice prompts to complete your request.

III. Comments

Interested persons may, by or before May 26, 1998 submit to the

Dockets Management Branch (address above) written comments regarding

these guidance documents. 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 for each guidance listed next to

the title of the document in the list found previously. If you wish to

comment on more than one guidance document, please submit a separate

comment for each guidance document for which you wish to submit a

comment. The guidance documents and received comments may be seen in

the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through

Friday.

After May 26, 1998, written comments may be submitted at any time

to Ron Jans (address above).

Dated: February 12, 1998

D. B. Burlington,

Director, Center for Devices and Radiological Health.

[FR Doc. 98-4841 Filed 2-20-98; 4:00 pm]

BILLING CODE 4160-01-F