[Federal Register: July 28, 2010 (Volume 75, Number 144)]

[Proposed Rules]

[Page 44172-44173]

From the Federal Register Online via GPO Access []





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.


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:

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


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, 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 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:, 301-796-6630.


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]