[Federal Register Volume 79, Number 113 (Thursday, June 12, 2014)]
[Proposed Rules]
[Page 33711]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-13705]


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 Proposed Rules
                                                 Federal Register
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 This section of the FEDERAL REGISTER contains notices to the public of 
 the proposed issuance of rules and regulations. The purpose of these 
 notices is to give interested persons an opportunity to participate in 
 the rule making prior to the adoption of the final rules.
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  Federal Register / Vol. 79, No. 113 / Thursday, June 12, 2014 / 
Proposed Rules  

[[Page 33711]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 860

[Docket No. FDA-2013-N-1529]


Medical Device Classification Procedures; Extension of Comment 
Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is extending the 
comment period for the proposed rule that appeared in the Federal 
Register of March 25, 2014. In the proposed rule, FDA requested 
comments on its proposal to amend its regulations governing 
classification and reclassification of medical devices to conform to 
the applicable provisions in the Food and Drug Administration Safety 
and Innovation Act (FDASIA), to update its regulations by proposing 
changes unrelated to the new FDASIA requirements, and to codify the 
procedures and criteria that apply to classification and 
reclassification of medical devices and to provide for classification 
of devices in the lowest regulatory class consistent with the public 
health and the statutory scheme for device regulation. The Agency is 
taking this action in response to requests for an extension to allow 
interested persons additional time to submit comments.

DATES: FDA is extending the comment period on the proposed rule 
published March 25, 2014 (79 FR 16252). Submit either electronic or 
written comments by September 22, 2014.

ADDRESSES: You may submit comments, identified by Agency name and 
Docket No. FDA-2013-N-1529, 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:
     Mail/Hand delivery/Courier (for paper 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. FDA-2013-N-1529 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 of 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: Marjorie Shulman, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 1536, Silver Spring, MD 20993-0002, 301-
796-6572; or Stephen Ripley, Center for Biologics Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of March 25, 2014 (79 FR 16252), FDA 
published a proposed rule with a 90-day comment period to request 
comments on the Agency's regulations governing classification and 
reclassification of medical devices to conform to the applicable 
provisions in FDASIA and proposed changes unrelated to the new FDASIA 
requirements to update its regulations governing classification and 
reclassification of medical devices. Comments on the proposed rule will 
inform FDA's rulemaking to establish regulations for governing 
classification and reclassification of medical devices to conform to 
the applicable provisions in FDASIA and proposed changes unrelated to 
the new FDASIA requirements to update its regulations governing 
classification and reclassification of medical devices.
    The Agency has received requests for an extension of the comment 
period for the proposed rule. Each request conveyed concern that the 
current 90-day comment period does not allow sufficient time to develop 
a meaningful or thoughtful response to the proposed rule. The Agency 
believes that a 90-day extension allows adequate time for interested 
persons to submit comments without significantly delaying rulemaking on 
these important issues.

II. Request for Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of 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, and will be posted to the docket at http://www.regulations.gov.

    Dated: June 6, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-13705 Filed 6-11-14; 8:45 am]
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