New Draft Guidance from FDA - Factors considered for Risk/Benefit Determination

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Marc

Hunkered Down for the Duration
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Admin
#3
Re: Benefit-Risk Determinations in Medical Devices - Guidance for Industry and FDA St

From the FDA site link above:

FDA said:
Draft Guidance for Industry and Food and Drug Administration Staff - Factors to Consider when Making Benefit-Risk Determinations in Medical Device Premarket Review

PDF Printer VersionThis guidance document is being distributed for comment purposes only.
Document issued on: August 15, 2011

You should submit comments and suggestions regarding this draft document within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov. Identify all comments with the docket number listed in the notice of availability that publishes in the Federal Register.

For questions regarding this document, contact Rachel Turow at 301-796-5094 or by electronic mail at [email protected]. For questions regarding this document concerning devices regulated by CBER, contact the Office of Communication, Outreach and Development (OCOD) by calling 1-800-835-4709 or 301-827-1800.
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Department of Health and Human Services
Food and Drug Administration

Center for Devices and Radiological Health
Center for Biologics Evaluation and Research
Preface
Additional Copies

Additional copies are available from the Internet. You may also send an e-mail request to [email protected] to receive an electronic copy of the guidance or send a fax request to 301-827-8149 to receive a hard copy. Please use the document number 1772 to identify the guidance you are requesting.
Table of Contents

Introduction
Scope
Background
3.1 The Statutory Standard for Safety and Effectiveness
3.2 Types of Scientific Evidence
3.3 Benefit-Risk Determinations
Factors FDA Considers in Making Benefit-Risk Determinations
4.1 Measures for Effectiveness of Devices
4.2 Measures for Safety of Devices
4.3 Additional Factors for Weighing Benefits and Risks of Devices
Examples of Benefit-Risk Determinations
5.1 Hypothetical Examples
5.2 Examples Based on Actual FDA Benefit-Risk Determinations

Appendix A - Worksheet for Benefit-Risk Determinations
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#5
Re: Benefit-Risk Determinations in Medical Devices - Guidance for Industry and FDA St

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