[Federal Register Volume 78, Number 1 (Wednesday, January 2, 2013)]
[Notices]
[Pages 100-101]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-31477]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-D-0523]
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 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 510(k)
submission is administratively complete, which determines whether it
should be accepted for substantive review and clearance. 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).
DATES: Submit either electronic or written comments on this guidance at
any time. General comments on Agency guidance documents are welcome at
any time.
ADDRESSES: Submit written requests for single copies of the guidance
document entitled ``Refuse to Accept Policy for 510(k)s'' to the
Division of Small Manufacturers, International and Consumer Assistance,
Center for 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
(CBER), 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 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.
SUPLEMENTARY INFORMATION:
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 (3) 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 from 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 (RTA) 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.
In the Federal Register of August 13, 2012 (77 FR 48159), FDA
announced the availability of the draft guidance document. Interested
persons were invited to comment by September 27, 2012. Eleven sets of
comments were received with multiple recommendations pertaining to the
administrative processes and policies regarding 510(k) acceptance
decisions.
A number of commenters expressed concern that the checklist
questions related to performance data implied that FDA staff would need
to conduct a level of substantive review in order to complete the
checklist. FDA has revised the language in these questions and added
further instructions to FDA staff to more specifically state that only
the presence of the information is required for acceptance, and that
the adequacy of the information should only be assessed after
acceptance and as part of the substantive review.
Similar comments were received regarding questions in the
checklists that identified an ``analysis'' or ``discussion'' as a
criterion for acceptance. Commenters were concerned that FDA staff
would be assessing the adequacy of the ``analysis'' or ``discussion''
in order to complete the checklist. These questions have also been
modified to explain more clearly that the acceptance criterion requires
only that the ``analysis'' or ``discussion'' be present; the adequacy
of this information should be assessed during the substantive review.
FDA received comments regarding relevant prior submissions and how
prior FDA feedback relevant to determining substantial equivalence has
been addressed in the submission under
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review. It was suggested that FDA identify a particular location within
the submission for this information, noting that such information could
be found in multiple locations. The guidance has been revised to
suggest more specific locations within the submission where this
information can be provided for the ease of compiling a 510(k) and to
facilitate FDA staff's acceptance review.
Other comments provided editorial suggestions for clarity and for
consistency with other FDA guidance documents. In response to these
comments, FDA revised the guidance document to clarify the processes
and policies as appropriate. This guidance supersedes the guidances
``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.
II. Significance of Guidance
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents 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 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.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 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 either written comments regarding
this document to the Division of Dockets Management (see ADDRESSES) or
electronic comments to http://www.regulations.gov. 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: December 26, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-31477 Filed 12-31-12; 8:45 am]
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