[Federal Register Volume 76, Number 157 (Monday, August 15, 2011)]
[Notices]
[Pages 50483-50484]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-20652]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0577]


Draft Guidance for Industry and Food and Drug Administration 
Staff; Factors to Consider When Making Benefit-Risk Determinations in 
Medical Device Premarket Review; 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availability of the draft guidance document entitled ``Factors to 
Consider When Making Benefit-Risk Determinations in Medical Device 
Premarket Review.'' The recommendations in this guidance are intended 
to provide greater clarity on FDA's decisionmaking process with regard 
to benefit-risk determinations in the premarket review of medical 
devices. This draft guidance is not final nor is it in effect at this 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draft guidance before it begins work on the final version of the 
guidance, submit electronic or written comments on the draft guidance 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 November 14, 2011.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Factors to Consider When Making Benefit-
Risk Determinations in Medical Device Premarket Review'' to the 
Division of Small Manufacturers, International, and Consumer 
Assistance, Center for Devices and Radiological Health (CDRH), 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, 
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    Submit electronic comments on the draft guidance to http://www.regulations.gov.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: For Devices Regulated by CDRH: Rachel 
Turow, Center for Devices and

[[Page 50484]]

Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, rm. 5449, Silver Spring, MD 20993-0002, 301-796-5094.
    For Devices Regulated by CBER: 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

    There are many factors that go into weighing the probable benefit 
of a device versus its probable risk. This draft guidance sets out the 
factors FDA considers when making this determination and explains them 
in detail. This draft guidance also gives examples of how the factors 
interrelate and how they may affect FDA's decisions. By clarifying 
FDA's decisionmaking process in this way, we hope to improve the 
predictability, consistency, and transparency of the review process for 
applicable devices.
    This draft guidance also includes for public comment a draft 
worksheet that reviewers may use in making benefit-risk determinations. 
The worksheet is attached as appendix A to the guidance. This level of 
documentation is very helpful to maintaining the consistency of review 
across the different review divisions and better assuring that an 
appropriate decision is reached.

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 factors 
to consider when making benefit-risk determinations in medical device 
premarket review. 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 either http://www.regulations.gov or 
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. To receive 
``Factors to Consider When Making Benefit-Risk Determinations in 
Medical Device Premarket Review'' from CDRH, you may either send an e-
mail 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 1772 to identify the guidance you are 
requesting.

IV. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this draft guidance contains no new 
collections of information. 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; 
and the collections of information in 21 CFR part 814 have been 
approved under OMB control number 0910-0231.

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: August 10, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-20652 Filed 8-12-11; 8:45 am]
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