[Federal Register Volume 62, Number 35 (Friday, February 21, 1997)]
[Notices]
[Pages 8024-8025]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-4303]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 95D-0283]


Deciding When to Submit a 510(k) for a Change to an Existing 
Device; Guidance; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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[[Page 8025]]

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance entitled ``Deciding When to Submit a 510(k) 
for a Change to an Existing Device.'' This guidance is intended to 
provide direction to manufacturers of devices who intend to modify 
their devices and are in the process of deciding whether the 
modification requires a new premarket notification submission (510(k)).

DATES: Written comments on this guidance may be submitted at any time.

ADDRESSES: Submit written requests for single copies of ``Deciding When 
to Submit a 510(k) for a Change to an Existing Device'' 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, 301-443-6597 (outside MD 1-800-638-2041). Send two 
self-addressed adhesive labels to assist that office in processing your 
requests, or fax your request to 301-443-8818. Copies of a facsimile of 
the guidance, are available from the Division of Small Manufacturers 
Assistance (DSMA) Facts on Demand, Center for Devices and Radiological 
Health (CDRH), 1-800-899-0381. Copies of the guidance may also be 
obtained from the World Wide Web at http://www.fda.gov/cdrh 
administered by DSMA and are available to anyone with a video terminal 
or personal computer (1-800-252-1366). Submit written comments on this 
guidance to the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. Two 
copies of any comments are to be submitted, except that individuals may 
submit one copy. Requests and comments should be identified with the 
docket number found in brackets in the heading of this document. A copy 
of the guidance and received comments are available for public 
examination in the Dockets Management Branch (address above) between 9 
a.m. and 4 p.m., Monday through Friday.

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: On April 8, 1994, FDA circulated for comment 
the first draft guidance entitled ``Deciding When to Submit a 510(k) 
for a Change to an Existing Device.'' The draft guidance was intended 
to provide direction to manufacturers on deciding when to submit a new 
510(k) for changes to an existing device. The April 8, 1994, draft 
guidance was the subject of a May 12, 1994, FDA teleconference and the 
subject of discussion at several trade and industry association 
meetings.
    FDA received over 60 comments regarding the April 8, 1994, draft 
guidance. Based on the comments received, FDA developed an August 1, 
1995, second draft guidance entitled ``Deciding When to Submit a 510(k) 
for a Change to an Existing Device.'' FDA received 11 comments 
regarding the October 16, 1996, draft guidance. The comments supported 
the October 16, 1996, draft guidance and suggested that FDA make the 
following changes: (1) Include the recent publication of the Quality 
Systems Regulation; (2) add more references for definition and as a 
referral to other guidance documents; (3) give more examples and 
explanation of materials, particularly with labeling changes and 
changes in material for in vitro devices; (4) update Appendix A on 
suggested material terminology to reflect latest industry comment on 
the biomaterials compendium; and (5) correct the logic flow in the 
materials change chart.
    Guidances have generally been issued under Sec. 10.90(b) (21 CFR 
10.90(b)), which provides for the use of guidances to state procedures 
or standards of general applicability that are not legal requirements, 
but that are acceptable to FDA. The agency is now in the process of 
revising Sec. 10.90(b). Therefore, the guidance is not being issued 
under the authority of current Sec. 10.90(b), and it does not create or 
confer any rights, privileges, or benefits for or on any person, nor 
does it operate to bind FDA or device manufacturers in any way.
    Interested persons may, at any time, submit to the Dockets 
Management Branch (address above) written comments on the guidance. 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 
found in brackets in the heading of this document. The guidance and 
received comments are available for public examination in the Dockets 
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.
    Received comments will be considered to determine if further 
revision of the guidance is warranted.

    Dated: February 4, 1997.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 97-4303 Filed 2-20-97; 8:45 am]
BILLING CODE 4160-01-F