[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Draft Guidance for Industry and Food and Drug Administration 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availability of the draft guidance entitled ``Refuse to Accept Policy 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 This draft guidance is 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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by September 27, 2012.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Refuse to Accept Policy for 510(k)s'' to 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    Submit electronic comments on the draft guidance to http://www.regulations.gov.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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