
[Federal Register Volume 79, Number 144 (Monday, July 28, 2014)]
[Notices]
[Pages 43753-43754]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-17666]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0652]


The 510(k) Program: Evaluating Substantial Equivalence in 
Premarket Notifications; 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 guidance entitled ``The 510(k) Program: Evaluating 
Substantial Equivalence in Premarket Notifications [510(k)].'' This 
guidance document describes FDA's current review practices for 
premarket notification (510(k)) submissions by describing in greater 
detail the regulatory framework, policies, and practices underlying 
FDA's review of traditional 510(k) submissions. This guidance document 
does not address the special and abbreviated 510(k) programs. FDA 
intends to finalize those sections separately.

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 ``The 510(k) Program: Evaluating Substantial 
Equivalence in Premarket Notifications [510(k)]'' 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 or the 
Office of Communication, Outreach and Development, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send 
one self-addressed adhesive label to assist that office in processing 
your request. 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: Marjorie Shulman, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 1536, Silver Spring, MD 20993-0002, 301-
796-6572; or Stephen Ripley, Center for Biologics Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    This guidance serves to identify, explain, and clarify each of the 
critical decision points in the decision-making process FDA uses to 
determine substantial equivalence under the 510(k) program. Since the 
program's inception in 1976, FDA has periodically published documents, 
including guidance

[[Page 43754]]

documents, which describe FDA's approach and any changes therein to the 
510(k) program. On June 30, 1986, FDA published a Blue Book Memorandum 
entitled ``Guidance on the CDRH Premarket Notification Review Program, 
510(k) Memorandum K86-3'' (the ``K86-3 Memorandum''). 
This document discussed general points regarding the process of 
determining substantial equivalence between a new device and a 
predicate device. On March 20, 1998, FDA published a guidance document 
entitled ``The New 510(k) Paradigm--Alternate Approaches to 
Demonstrating Substantial Equivalence in Premarket Notifications'' 
(``the New 510(k) Paradigm''). This guidance introduced two new 510(k) 
programs--the Special 510(k) and the Abbreviated 510(k)--as optional 
approaches available to device manufacturers and renames the original 
510(k) program that had been in place since 1976 to the ``Traditional 
510(k).'' Traditional, Special, and Abbreviated 510(k)s differ with 
respect to the scope and content of information that are included 
within the submission. It is noted that the K86-3 Memorandum 
was issued as a final guidance prior to the February 27, 1997, 
implementation of FDA's Good Guidance Practices, 21 CFR 10.115. Neither 
the K86-3 Memorandum nor the New 510(k) Paradigm has been 
updated since its initial publication. As further explained later in 
this section, this new guidance document will replace only the 
K86-3 Memorandum.
    On December 28, 2011, FDA announced the availability of ``Draft 
Guidance for Industry and Food and Drug Administration Staff: The 
510(k) Program: Evaluating Substantial Equivalence in Premarket 
Notifications [510(k)]'' (76 FR 81510) (the ``Draft Guidance''). 
Interested persons were invited to comment by April 26, 2012. FDA 
received 26 sets of comments, totaling over 400 comments. While the 
sections on Special 510(k), technological characteristics, and 
predicate devices received the most comments, there were also requests 
for inclusion of examples to assist in defining the gray areas of how 
FDA interprets what would be considered substantially equivalent under 
the 510(k) program.
    In response to these comments, the guidance was revised to provide 
a broader overview of the use of predicate devices and to explain more 
clearly the intent and value of defining a ``primary predicate'' device 
in the submission. Examples were added to several sections to clarify 
the boundaries and FDA's decision-making process for finding devices 
equivalent to a predicate that may have different indications for use, 
technological characteristics, or performance characteristics. There 
were requests for the addition of a ``fillable form'' to ensure 
consistency in the amount and type of detail expected in a 510(k) 
summary. In response, an appendix was added with a sample 510(k) 
summary, including clinical data, to demonstrate the level of detail 
that is expected in each regulatory mandated section upon finalization 
of the guidance to increase transparency.
    Lastly, industry expressed concern relating to the inclusion of the 
Special 510(k) Program within this guidance, given the connection of 
this topic and determining when it is necessary to submit a new 510(k) 
for a device modification. In response, FDA elected to remove the 
sections addressing the alternatives to Traditional 510(k)s, 
specifically the Special and Abbreviated 510(k) programs that were 
included in the draft guidance. FDA intends to finalize these sections 
separately. Until FDA issues a new final guidance document on the 
Special and Abbreviated 510(k) Programs, the recommendations for 
Special and Abbreviated 510(k)s contained in the New 510(k) Paradigm 
remain in effect for these alternate submission types.
    In response to other minor substantive and editorial comments, FDA 
revised the guidance document to clarify the processes and policies as 
appropriate.

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 510(k) Program: Evaluating 
Substantial Equivalence in Premarket Notifications [510(k)].'' 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 
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 or http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. Persons unable to 
download an electronic copy of ``The 510(k) Program: Evaluating 
Substantial Equivalence in Premarket Notifications [510(k)]'' may send 
an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic 
copy of the document. Please use the document number 1766 to identify 
the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This 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 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR part 820 have been approved under 
OMB control number 0910-0073; the collections of information in 21 CFR 
part 812 have been approved under OMB control number 0910-0078; the 
collections of information in 21 CFR 807 subpart E have been approved 
under OMB control number 0910-0120; the collections of information in 
21 CFR 56.115 have been approved under OMB control number 0910-0130; 
the collections of information found in 21 CFR part 814 have been 
approved under OMB control number 0910-0231; the collections of 
information in 21 CFR part 803 have been approved under OMB control 
number 0910-0437; and the collections of information in 21 CFR part 801 
have been approved under OMB control number 0910-0485.

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 23, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-17666 Filed 7-25-14; 8:45 am]
BILLING CODE 4164-01-P


