U.S. flag An official website of the United States government
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices
  1. Search for FDA Guidance Documents

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

Final

This guidance is being distributed for comment purposes only.

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

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.