[Federal Register Volume 75, Number 144 (Wednesday, July 28, 2010)]
[Notices]
[Page 44267]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-18406]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0495]
Draft Guidance for Industry and Food and Drug Administration
Staff; Medical Devices; Neurological and Physical Medicine Device
Guidance Document; Reopening of Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; reopening of comment period.
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SUMMARY: The Food and Drug Administration (FDA) is reopening until
September 7, 2010, the comment period for the notice that appeared in
the Federal Register of April 5, 2010 (75 FR 17143). In the notice, FDA
requested comments on draft guidance documents for 11 neurological and
physical medicine devices. FDA is reopening the comment period to allow
further comment and to receive any new information.
DATES: Submit either electronic or written comments by September 7,
2010.
ADDRESSES: Submit electronic comments to http://www.regulations.gov.
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Robert J. DeLuca, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. G214, Silver Spring, MD 20993-0002, e-
mail: [email protected], 301-796-6630.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of April 5, 2010 (75 FR 17093), FDA
published a notice announcing the availability of draft special
controls guidance documents for 11 neurological and physical medicine
devices. Interested persons were originally given until July 6, 2010,
to comment on the draft guidance documents. The agency expressed
specific interest in comments on the types of claims appropriate for
devices included within the 11 classifications and, for devices that
remain subject to premarket review, the data sponsors should submit to
support those claims.
II. Request for Comments
Following publication of the April 5, 2010, notice, FDA received
requests to allow interested persons additional time to comment. The
requests asserted that the 90-day time period was insufficient to
respond fully to FDA's specific requests for comments and to allow
potential respondents to thoroughly evaluate and address pertinent
issues. The agency has considered the requests and is reopening the
comment period until September 7, 2010. The agency believes the
additional comment period allows adequate time for interested persons
to submit comments without significantly delaying rulemaking on these
important issues.
III. How to Submit Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
Dated: July 22, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-18406 Filed 7-27-10; 8:45 am]
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