Document ID: FDA-2009-N-0493-0013
Agency: fda
Document Type: Proposed Rule
Title: Neurological and Physical Medicine Devices; Designation of Special Controls for Certain Class II Devices and Exemption From Premarket Notification; Reopening of the Comment Period
Posted Date: 2010-07-28T04:00Z

[Federal Register: July 28, 2010 (Volume 75, Number 144)]
[Proposed Rules]               
[Page 44172-44173]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28jy10-27]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 882 and 890

[Docket No. FDA-2009-N-0493]
RIN 0910-ZA37

 
Neurological and Physical Medicine Devices; Designation of 
Special Controls for Certain Class II Devices and Exemption From 
Premarket Notification; Reopening of the Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; reopening of the comment period.

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SUMMARY: The Food and Drug Administration (FDA) is reopening until 
September 7, 2010, the comment period for the proposed rule published 
in the Federal Register of April 5, 2010 (75 FR 17093). The document 
proposed to amend certain neurological and physical medicine device 
regulations to establish special controls for these class II devices 
and to exempt some of these devices from premarket notification 
requirements. FDA is reopening the comment period to allow further 
comment and to receive any new information.

DATES: Submit electronic or written comments by September 7, 2010.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2009-
N-0493, and/or RIN number 0910-ZA37, by any of the following methods:
Electronic Submissions
Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
Written Submissions
Submit written submissions in the following ways:
     FAX: 301-827-6870.
     Mail/Hand delivery/Courier (for paper, disk, or CD--ROM 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration,

[[Page 44173]]

5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the agency name 
and Docket No. and Regulatory Information Number (RIN) (if a RIN number 
has been assigned) for this rulemaking. All comments received may be 
posted without change to http://www.regulations.gov, including any 
personal information provided. For additional information on submitting 
comments, see the ``Comments'' heading in the SUPPLEMENTARY INFORMATION 
section of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov and insert the 
docket number, found in brackets in the heading of this document, into 
the ``Search'' box and follow the prompts and/or go to the Division of 
Dockets Management, 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, 
email: 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 proposed rule to amend certain neurological device and 
physical medicine device regulations to establish special controls for 
these class II devices and to exempt some of these devices from the 
premarket notification requirements of the Federal Food, Drug, and 
Cosmetic Act. Interested persons were given until July 6, 2010, to 
comment on the proposed rule.

II. Request for Comments

    Following publication of the April 5, 2010, proposed rule, 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. 2010-18405 Filed 7-27-10; 8:45 am]
BILLING CODE 4160-01-S