[Federal Register Volume 79, Number 135 (Tuesday, July 15, 2014)]
[Notices]
[Pages 41289-41290]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-16565]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0900]


Benefit-Risk Factors To Consider When Determining Substantial 
Equivalence in Premarket Notifications [510(k)] With Different 
Technological Characteristics; Draft Guidance for Industry and Food and 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availability of the draft guidance document entitled ``Benefit-Risk 
Factors to Consider When Determining Substantial Equivalence in 
Premarket Notifications [510(k)] with Different Technological 
Characteristics.'' This guidance is intended to provide greater clarity 
regarding the principal benefit-risk factors that FDA considers during 
the review process for a premarket notification (510(k)) submission 
when there are different technological characteristics between the new 
device and the legally marketed (predicate)

[[Page 41290]]

device. This draft guidance is not final nor is it in effect at this 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draft guidance before it begins work on the final version of the 
guidance, submit electronic or written comments on the draft guidance 
by October 14, 2014.

ADDRESSES: An electronic copy of the guidance document is available for 
download from the Internet. See the SUPPLEMENTARY INFORMATION section 
for information on electronic access to the guidance. Submit written 
requests for a single hard copy of the guidance document entitled 
``Benefit-Risk Factors to Consider When Determining Substantial 
Equivalence in Premarket Notifications [510(k)] with Different 
Technological Characteristics'' 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.
    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: Office of Center Director, Center for 
Devices and Radiological Health, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 66, Silver Spring, MD 20993-0002, 301-796-
5900, 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, 240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    A submitter of a premarket notification submission (510(k)) must 
demonstrate to FDA in its 510(k) submission that the new device is 
``substantially equivalent'' to a ``predicate device'' (see section 
513(i) of the Federal Food, Drug & Cosmetic Act (21 U.S.C. 360c(i)). At 
certain points in the substantial equivalence analysis, the probable 
benefits and risks of a new device as compared to a legally marketed 
(predicate) device may be relevant. This draft guidance does not focus 
on benefit-risk factors that may be considered during the first step of 
the 510(k) review process where FDA must find that the intended use of 
the device and the predicate device are ``the same.'' Instead, this 
guidance focuses on the step of the 510(k) review process after FDA has 
determined that there are different technological characteristics 
between the new device and the predicate device, and FDA has determined 
that the differences in the technological characteristics do not raise 
different questions of safety and effectiveness. At this step in the 
review process, FDA must determine whether the new device is ``as safe 
and effective'' as the predicate device. This draft guidance discusses 
the principal benefit-risk factors FDA considers when making this 
determination, and also provides examples of how these factors may be 
used during premarket review.
    The benefit-risk factors discussed in this guidance may assist FDA 
reviewers in making substantial equivalence determinations and may help 
accommodate evolving technology during the 510(k) premarket process. 
This guidance may also help submitters of 510(k) premarket 
notifications demonstrate substantial equivalence in their premarket 
submissions. FDA has developed this guidance in order to improve the 
predictability, consistency, and transparency of the 510(k) premarket 
review process. This guidance does not change the 510(k) premarket 
review standard or create extra burden on a submitter of a 510(k) to 
provide additional performance data from what has traditionally been 
submitted during the review process for 510(k) submissions.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). This draft guidance, 
when finalized, will represent the Agency's current thinking on 
benefit-risk factors to consider when determining substantial 
equivalence in medical device premarket notifications (510(k)) with 
different technological characteristics. 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. or http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. Persons unable to 
download an electronic copy of ``Benefit-Risk Factors to Consider When 
Determining Substantial Equivalence in Premarket Notifications [510(k)] 
with Different Technological Characteristics,'' may send an email 
request to [email protected] to receive an electronic copy of 
the document. Please use the document number 1818 to identify the 
guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    The 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; and the collections of 
information in 21 CFR part 803 have been approved under OMB control 
number 0910-0437.

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 necessary to send 
only 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 10, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-16565 Filed 7-14-14; 8:45 am]
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