[Federal Register Volume 63, Number 37 (Wednesday, February 25, 1998)]
[Pages 9570-9571]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-4841]



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

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


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 

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-

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 

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 
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 
    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]