[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
