[Federal Register Volume 77, Number 60 (Wednesday, March 28, 2012)]
[Notices]
[Pages 18828-18829]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-7418]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Guidance for Industry and Food and Drug Administration Staff; 
Factors To Consider When Making Benefit-Risk Determinations in Medical 
Device Premarket Approval and de Novo Classifications; 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 document entitled ``Factors to Consider 
When Making Benefit-Risk Determinations in Medical Device Premarket 
Approval and De Novo Classifications.'' This guidance is intended to 
provide greater clarity on FDA's decisionmaking process with regard to 
benefit-risk determinations in the premarket review of medical devices 
in the premarket approval and de novo pathways.

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 ``Factors to Consider When Making Benefit-Risk 
Determinations in Medical Device Premarket Approval and De Novo 
Classifications'' 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, Rockville, MD 20852-1448. Send one 
self-addressed adhesive label to assist 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 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: Ruth Fischer, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 4424, Silver Spring, MD 20993-0002, 301-796-5735.
    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 assessing the probable benefit 
of a device versus its probable risk. This guidance sets out the 
principal factors FDA considers when making this determination and 
explains them in detail. This 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. The factors described in this guidance apply to 
devices submitted under premarket approval applications and de novo 
petitions.
    This guidance also includes a worksheet that reviewers will use in 
making benefit-risk determinations for applicable devices. The 
worksheet is attached as Appendix B to the guidance, and examples of 
how reviewers might use the worksheet are attached as Appendix C 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.
    In the Federal Register of August 15, 2011 (76 FR 50483), FDA 
announced the availability of the draft guidance. Interested persons 
were invited to comment by November 14, 2011. FDA considered the 
comments and revised the guidance, 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 factors to consider when making benefit-
risk determinations in medical device premarket approval and de novo 
classifications. 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 is available for all CDRH 
guidance documents 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 Approval and De Novo Classifications'' from 
CDRH, you may either send an email 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 concludes that this guidance contains no new collections of 
information. The guidance refers to currently approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of

[[Page 18829]]

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. 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: March 22, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-7418 Filed 3-27-12; 8:45 am]
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