[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Draft Guidance for Industry and Food and Drug Administration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availability of the draft guidance document entitled ``Factors to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 This draft guidance is not final nor is it in effect at this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draft guidance before it begins work on the final version of the
guidance, submit electronic or written comments on the draft guidance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ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Factors to Consider When Making Benefit-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Submit electronic comments on the draft guidance to http://www.regulations.gov.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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