2010-18405. 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: http://www.regulations.gov. Follow the instructions for submitting comments.

Written Submissions

Submit written submissions in the following ways:

• FAX: [phone].
• Mail/Hand delivery/Courier (for paper, disk, or CD—ROM submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 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: [e-mail], 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.