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GUIDANCE DOCUMENT

Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions Guidance for Investigational Device Exemption Sponsors, Sponsor-Investigators and Food and Drug Administration Staff January 2017

Download the Final Guidance Document
Final
Docket Number:
FDA-2015-D-1777
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health
Center for Biologics Evaluation and Research

FDA is committed to improving U.S. patient access to new devices by strengthening and streamlining the clinical trial enterprise so that medical device clinical trials are conducted in the U.S. in an efficient and cost-effective manner, while maintaining appropriate patient and research participant protections.

The purpose of this guidance is to provide greater clarity for FDA staff and investigational device exemption (IDE) sponsors and sponsor-investigators1 regarding the principal factors that FDA considers when assessing the benefits and risks of IDE applications for human clinical studies.

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Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2015-D-1777.

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