Document ID: FDA-2014-D-0967-0001
Agency: fda
Document Type: Notice
Title: Intent To Exempt Certain Class II and Class I Reserved Medical Devices
From Premarket Notification Requirements; Draft Guidance for
Industry and Food and Drug Administration Staff; Availability
Posted Date: 2014-08-01T04:00Z

[Federal Register Volume 79, Number 148 (Friday, August 1, 2014)]
[Notices]
[Pages 44804-44805]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-18198]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0967]

Intent To Exempt Certain Class II and Class I Reserved Medical 
Devices From Premarket Notification Requirements; Draft Guidance for 
Industry and Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the draft guidance entitled ``Intent to Exempt Certain 
Class II and Class I Reserved Medical Devices from Premarket 
Notification Requirements.'' This draft guidance describes FDA's intent 
to exempt certain Class II medical devices and certain Class I medical 
devices, subject to the reserved criteria, from premarket notification 
requirements. FDA believes devices identified in this guidance document 
are sufficiently well understood and do not present risks that require 
premarket notification review to assure their safety and effectiveness. 
This draft guidance is not final nor is it in effect at this time.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by September 30, 2014.

ADDRESSES: An electronic copy of the guidance document is available for 
download from the Internet. See the SUPPLEMENTARY INFORMATION section 
for information on electronic access to the guidance. Submit written 
requests for a single hard copy of the draft guidance document entitled 
``Intent to Exempt Certain Class II and Class I Reserved Medical 
Devices from Premarket Notification Requirements'' to the Office of the 
Center Director, Guidance and Policy Development, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002. Send 
one self-addressed adhesive label to assist that office in processing 
your request.
    Submit electronic comments on the draft guidance 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. Identify comments with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Abiy Desta, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1682, Silver Spring, MD 20993-0002, 301-796-0293.

SUPPLEMENTARY INFORMATION:

I. Background

    In the commitment letter (section 1.G of the Performance Goals and 
Procedures) that was drafted as part of the reauthorization process for 
the Medical Device User Fee Amendments of 2012 (Pub. L. 112-144), FDA 
committed to identifying low-risk medical devices to exempt from 
premarket notification. This draft guidance describes FDA's intent to 
exempt certain Class II medical devices and certain Class I medical 
devices that are subject to the reserved criteria of section 510(l) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(l)) from 
premarket submission requirements. FDA believes devices identified in 
this guidance document are sufficiently well understood and do not 
present risks that require 510(k) review.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the Agency's current thinking on identifying 
low risk medical devices to exempt from premarket notification. It does 
not create or confer any rights for or on any person and does not 
operate to bind FDA or the public. An alternative approach may be used 
if such approach satisfies the requirements of the applicable statute 
and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do 
so by downloading an electronic copy from the Internet. A search 
capability for all Center for Devices and Radiological Health guidance 
documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available at http://www.regulations.gov. To receive 
``Intent to Exempt Certain Class II and Class I Reserved Medical 
Devices from Premarket Notification Requirements,'' you may send an 
email request to CDRH-Guidance@fda.hhs.gov to receive an electronic 
copy of the document. Please use the document number 1300046 to 
identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995

[[Page 44805]]

(44 U.S.C. 3501-3520). The collections of information in 21 CFR part 
807, subpart E, have been approved under OMB control number 0910-0120.

V. 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: July 29, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-18198 Filed 7-31-14; 8:45 am]
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