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GUIDANCE DOCUMENT

Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices Guidance for Industry and Food and Drug Administration Staff August 2017

Download the Final Guidance Document
Final
Docket Number:
FDA-2016-D-2153
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

FDA is issuing this guidance to clarify how we evaluate real-world data to determine whether they are sufficient for generating the types of real-world evidence that can be used in FDA regulatory decision-making for medical devices. This guidance is applicable to all devices, as that term is defined under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), including software that meets the definition of a device.

Submit Comments

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-2016-D-2153.

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