[Federal Register Volume 77, Number 156 (Monday, August 13, 2012)]
[Notices]
[Pages 48159-48160]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-19744]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-D-0523]
Draft Guidance for Industry and Food and Drug Administration
Staff; Refuse To Accept Policy for 510(k)s; 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availability of the draft guidance entitled ``Refuse to Accept Policy
for 510(k)s.'' The purpose of this document is to explain the
procedures and criteria FDA intends to use in determining whether a
premarket notification (510(k)) submission is administratively
complete, which determines whether it should be accepted for
substantive review. This guidance is applicable to 510(k)s reviewed in
the Center for Devices and Radiological Health (CDRH) and the Center
for Biologics Evaluation and Research (CBER). This draft guidance is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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by September 27, 2012.
ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Refuse to Accept Policy for 510(k)s'' to
the Division of Small Manufacturers, International and Consumer
Assistance, Center for
[[Page 48160]]
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, rm. 4613, Silver Spring, MD 20993-0002;
or Office of Communication, Outreach and Development (HFM-40), Center
for Biologics Evaluation and Research, Food and Drug Administration,
1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448. Send one
self-addressed adhesive label to assist that office in processing your
request, or fax your request to 301-847-8149. See the SUPPLEMENTARY
INFORMATION section for information on electronic access to the
guidance.
Submit electronic comments on the draft guidance to http://www.regulations.gov.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: Geeta Pamidimukkala, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, rm. 1564, Silver Spring, MD 20993-0002,
301-796-6453; or Stephen Ripley, Center for Biologics Evaluation and
Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike,
Suite 200N, Rockville, MD 20852-1448, 301-827-6210.
I. Background
The purpose of the 510(k) acceptance review is to make a threshold
determination whether a submission is administratively complete, which
determines whether it should be accepted for substantive review to
reach a determination regarding substantial equivalence under section
513(i) of the FD&C Act, 21 U.S.C. 360c(i). To find a device
substantially equivalent under section 513(i) of the FD&C Act, FDA must
find that it has the same intended use as the predicate device, and
either: (1) Has the same technological characteristics as the predicate
device or (2) has different technological characteristics, as defined
at section 513(i)(1)(B), and the submission contains information,
including appropriate clinical or scientific data if necessary, that
demonstrates the device is as safe and effective as the predicate and
does not raise different questions of safety and effectiveness than the
predicate.
The purpose of this document is to explain the procedures and
criteria FDA intends to use in determining whether a 510(k) submission
is administratively complete and should be accepted for substantive
review. This guidance document provides updated information to two
existing guidance documents entitled ``Center for Devices and
Radiological Health's Premarket Notification (510(k)) Refuse to Accept
Policy'' issued on June 30, 1993, and ``510(k) Refuse to Accept
Procedures, 510(k) Memorandum K94-1'' issued on May 20, 1994. Upon
issuance as a final guidance document, this guidance will replace those
documents.
To further focus the Agency's review resources on complete
applications, which will provide a more efficient approach to ensuring
that safe and effective medical devices reach patients as quickly as
possible, we have modified the 1993 and 1994 guidances. For example, we
have modified the 510(k) refuse to accept policy to include an early
review against specific acceptance criteria and to inform the submitter
within the first 15 calendar days of receipt of the submission if the
submission is administratively complete, or if not, to identify the
missing element(s). In order to enhance the consistency of our
acceptance decisions and to help submitters better understand the types
of information FDA needs to conduct a substantive review, this
guidance, including the checklists included in the appendices,
clarifies the necessary elements and contents of a complete 510(k)
submission. These elements are applicable to all devices reviewed
through the 510(k) notification process in CDRH and CBER and have been
compiled into checklists for use by FDA review staff.
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 the refuse
to accept policy for 510(k)s. 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 using the Internet. A search capability for all CDRH guidance
documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm or http://www.regulations.gov.
To receive ``Refuse to Accept Policy for 510(k)s,'' you may either
send an email request to [email protected] to receive an electronic
copy of the document or send a fax request to 301-847-8149 to receive a
hard copy. Please use the document number 1793 to identify the guidance
you are requesting.
IV. Paperwork Reduction Act of 1995
This draft guidance refers to currently 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 (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 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. 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: August 7, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-19744 Filed 8-10-12; 8:45 am]
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