Document ID: FDA-2009-D-0495-0023
Agency: fda
Document Type: Notice
Title: Draft Guidance for Industry and Food and Drug Administration Staff: Medical Devices; Neurological and Physical Medicine Device Guidance Document
Posted Date: 2010-07-28T04:00Z

[Federal Register: July 28, 2010 (Volume 75, Number 144)]
[Notices]               
[Page 44267]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28jy10-83]                         

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

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Draft Guidance for Industry and Food and Drug Administration 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.

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

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requested comments on draft guidance documents for 11 neurological and 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: Robert.DeLuca@fda.hhs.gov, 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to comment on the draft guidance documents.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]
BILLING CODE 4160-01-S