[Federal Register Volume 79, Number 148 (Friday, August 1, 2014)]
[Notices]
[Pages 44804-44805]
From the Federal Register Online via the Government Publishing 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Devices From Premarket Notification Requirements; Draft Guidance for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availability of the draft guidance entitled ``Intent to Exempt Certain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 This draft guidance describes FDA's intent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This draft guidance is not final nor is it in effect at this time.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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by September 30, 2014.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requests for a single hard copy of the draft guidance document entitled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Submit electronic comments on the draft guidance to http://www.regulations.gov.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 [email protected] 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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