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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

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

Detailed guidance document from FDA and regulatory agencies.

Document Details

Guidance Document

August 31, 2017

June 26, 2023

Center for Devices and Radiological Health

1de17575-088a-4770-a70b-99c29f9cf44d

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