[Federal Register Volume 63, Number 25 (Friday, February 6, 1998)]
[Notices]
[Pages 6193-6194]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 98-3002]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98D-0003]


FDA Modernization Act of 1997: Guidance for the Device Industry 
on Implementation of Highest Priority Provisions; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance entitled ``FDA Modernization Act of 1997: 
Guidance for the Device Industry on Implementation of Highest Priority 
Provisions; Availability.'' This guidance, generally referred to as the 
``Day-1 guidance'' summarizes FDA's strategy for implementing the 
highest priority provisions of the FDA Modernization Act of 1997 
(FDAMA) as it relates to the regulation of medical devices. The agency 
requests comments on this guidance.

DATES: Submit written comments by May 7, 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. Submit written requests for single copies of the 
guidance entitled ``FDA Modernization Act of 1997: Guidance for the 
Device Industry on Implementation of the Highest Priority Provisions'' 
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: Joseph M. Sheehan, Center for Devices 
and Radiological Health (HFZ-1), Food and Drug Administration, 1350 
Picard Dr., Rockville, MD 20850, 301-443-4690.

SUPPLEMENTARY INFORMATION:

I. Background

    The ``Day-1 guidance'' announced in this document summarizes FDA's 
strategy for implementing the highest priority provisions of the FDAMA 
(Pub. L. 105-115) as it relates to the regulation of medical devices. 
FDA identified these provisions as being of the highest priority for 
implementation because: (1) They become effective on or before February 
19, 1998, the general effective date of the act; (2) they are expected 
to impact a large number of products/applications; or (3) they are of 
high interest to the device community. Unless an alternative method of 
implementation is specified in the statute, FDA generally plans to 
issue individual guidance documents to implement these provisions of 
the new law. The highest priority provisions of FDAMA identified in the 
guidance, and related sections in FDAMA, are:
    (1) Early collaboration on data requirements for clinical studies 
(sections 201 and 205),
    (2) Premarket approval application (PMA) collaborative review 
process (section 209),
    (3) Scope of review: labeling claims for PMA's (section 205),
    (4) PMA supplements for manufacturing changes (section 205),
    (5) Premarket notification exemptions (section 206),
    (6) Evaluation of automatic class III designation (section 207),
    (7) Device standards (section 204),
    (8) Scope of review: labeling claims for 510(k)'s (section 205),
    (9) 90-Day review of 510(k)'s (section 209),
    (10) Device tracking (section 211),
    (11) Postmarket surveillance (section 212), and
    (12) Dispute resolution (section 404).
    The ``Day-1 guidance'' provides a section-by-section summary of 
each of these statutory provisions and describes FDA's general approach 
to implementing each such provision.
    In accordance with FDA's Good Guidance Practices (62 FR 8961, 
February 27, 1997), this Level 1 guidance is being issued without prior 
public comment because it affects immediate implementation of new 
statutory requirements. Comments and suggestions regarding this 
guidance may be submitted by May 7, 1998. Unless specified otherwise, 
other guidances referenced in this guidance will also be issued as 
Level 1 guidances that become effective upon publication, with the 
opportunity to submit comments to the agency during the implementation 
stage.
    This guidance represents the agency's current thinking on the 
implementation

[[Page 6194]]

of the FDAMA. It does not create or confer any rights for or on any 
person and does not operate to bind FDA or the public. An alternative 
approach may be used if such approach satisfies the requirement of the 
applicable statute, regulations, or both.

II. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so 
using the World Wide Web (WWW). The Center for Devices and Radiological 
health (CDRH) maintains an entry on the WWW for easy access to 
information including text, graphics, and files that may be downloaded 
to a personal computer with access to the Web. The CDRH home page, 
which is updated on a regular basis, includes the guidance entitled 
``FDA Modernization Act of 1997: Guidance for the Device Industry on 
Implementation of Highest Priority Provisions,'' 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 guidance will be available on the CDRH 
home page at http://www.fda.gov/cdrh.
    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.

III. Comments

    Interested persons may, on or before May 7, 1998, submit written 
comments on the guidance to the Dockets Management Branch (address 
above). Two copies of any comments are to be submitted, except that 
individuals may submit one copy. Comments and requests for copies are 
to be identified with the docket number found in brackets in the 
heading of this document. The guidance and received comments may be 
seen in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday 
through Friday.

    Dated: January 13, 1998.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 98-3002 Filed 2-5-98; 8:45 am]
BILLING CODE 4160-01-F