[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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

[[Page 101]]

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]
BILLING CODE 4160-01-P