Notice: Draft Guidance for Industry and Food and Drug Administration 
Staff; the 510(k) Program: Evaluating Substantial Equivalence in 
Premarket Notifications [510(k)]; Availability

Federal Register: Volume 76, Number 249 (Wednesday, December 28, 2011)
                  Pages 81510-81511

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the draft guidance entitled ``Draft Guidance for 
Industry and Food and Drug Administration Staff; The 510(k) Program: 
Evaluating Substantial Equivalence in Premarket Notifications 
[510(k)].'' FDA developed this draft guidance document to provide a 
contemporary perspective on how FDA reviews premarket notification 
(510(k)) submissions as well as on the Special and Abbreviated 510(k) 
programs. This guidance addresses the major aspects of the 510(k) 
decision-making process and updates FDA's policies with respect to the 
Special and Abbreviated 510(k) programs. This draft guidance is not 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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by April 26, 2012.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Draft Guidance for Industry and Food and 
Drug Administration Staff; The 510(k) Program: Evaluating Substantial 
Equivalence in Premarket Notifications [510(k)]'' 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 
to the Office of Communication, Outreach and Development (HFM-40), 
Center for Biologics Evaluation and Research (CBER), Food and Drug 
Administration, 1401 Rockville Pike, 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    Submit electronic comments on the draft guidance to http://www.regulations.gov.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:
Jonette Foy, Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1676, Silver 
Spring, MD 20993-0002, (301) 796-6328;
or
Stephen Ripley, Center for Biologics Evaluation and Research (HFM-17), 
Food and Drug Administration, 1401 Rockville Pike, Suite 200N, 
Rockville, MD 20852, (301) 827-6210.

SUPPLEMENTARY INFORMATION

I. Background

    This draft guidance serves to update FDA's perspective on the 
Agency's approach to the 510(k) program, which began in 1976. Since 
that time, FDA has periodically published guidance that described its 
approach and any changes therein, to the 510(k) program. On June 30, 
1986, FDA published a Blue Book Memorandum titled ``Guidance on the 
CDRH Premarket Notification Review Program, 510(k) Memorandum 
K86-3,'' a document which discussed general points regarding 
the process of determining substantial equivalence between a new device 
and a predicate device. On March 20, 1998, FDA published another 
guidance document titled ``The New 510(k) Paradigm--Alternate 
Approaches to Demonstrating Substantial Equivalence in Premarket 
Notifications.'' This guidance introduced two new 510(k) programs--the 
Special 510(k) and the Abbreviated 510(k)--as optional approaches 
available to device manufacturers. This guidance also renamed 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. The Special 510(k) is an option for a 
manufacturer who has made certain changes to a medical device that was 
previously found substantially equivalent. With this option, the 
manufacturer relies on conformance with design controls under the 
Quality System Regulation (21 CFR 820.30) to support substantial 
equivalence. The Abbreviated 510(k) is an option for manufacturers who 
rely on guidance documents, special controls, and/or recognized 
consensus standards to support substantial equivalence. These alternate 
approaches were intended to streamline FDA's review process and 
simplify for manufacturers the preparation of a 510(k) that was 
eligible for these programs. It is noted that the 1986 guidance was 
issued as final guidance prior to the February 27, 1997, implementation 
of FDA's Good Guidance Practices (GGPs). Neither guidance has been 
updated since its initial publication. Upon its issuance as a final 
guidance document, this new guidance will replace both of those 
guidances.
    In recent years, concerns have been raised both within and outside 
of FDA about whether the 510(k) program optimally achieves its intended 
goals. In September 2009, FDA's Center for Devices and Radiological 
Health (CDRH) convened an internal 510(k) Working Group to conduct a 
comprehensive assessment of the 510(k) process. The 510(k) Working 
Group evaluated the 510(k) program with the goal of strengthening the 
program and improving the predictability, consistency, and transparency 
of the Agency's decision-making process. On February 18, 2010, the 
510(k) Working Group held a public meeting to solicit comments from the 
public regarding the strengths and challenges associated with the 
510(k) program. In August 2010, CDRH published two documents in 
consideration of the comments made at the public meeting and the 
Agency's preliminary assessment of the program. These documents are 
titled ``CDRH Preliminary Internal Evaluations--Volume I: 510(k) 
Working Group Preliminary Report and Recommendations'' and ``CDRH 
Preliminary Internal Evaluations--Volume II: Task Force on the 
Utilization of Science in Regulatory Decision Making Preliminary Report 
and

[[Page 81511]]

Recommendations.'' In January 2011, CDRH published the ``Plan of Action 
for Implementation of 510(k) and Science Recommendations,'' denoting as 
one of the action items to update the 1998 510(k) Paradigm Guidance.
    FDA recognizes and supports efforts for global convergence of 
regulatory systems, and in particular, through its participation in the 
Global Harmonization Task Force which published the ``Summary Technical 
Documentation for Demonstrating Conformity to the Essential Principles 
of Safety and Performance of Medical Devices (STED)'' on February 21, 
2008. The Agency has specifically considered the STED principles in the 
FDA Guidance titled ``Guidance for Industry and FDA Staff: Format for 
Traditional and Abbreviated 510(k)s'' and has also incorporated those 
principles in this guidance as appropriate. FDA is specifically 
interested in seeking comment with respect to how these principles may 
be further applied in this guidance document and to 510(k) submissions 
and review generally.

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 510(k) 
decision-making process and policies with respect to the 510(k) 
program. 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.regulations.gov or from CBER 
at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm.
    To receive ``Draft Guidance for Industry and Food and Drug 
Administration Staff; The 510(k) Program: Evaluating Substantial 
Equivalence in Premarket Notifications [510(k)],'' you may either send 
an email request to dsmica@fda.hhs.gov 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 1766 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 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 part 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 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. It is no 
longer necessary to send two copies of mailed 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: December 21, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-33232 Filed 12-27-11; 8:45 am]
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