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05
Oct
The U.S. Food and Drug Administration (FDA) is making efforts to modernize both the 510(k) approval process for medical devices and study designs for drugs and biologics.
On September 7, 2023, the FDA Center for Devices and Radiological Health (CDRH) issued three draft device guidances:
1) Best Practices for Selecting a Predicate Device to Support a Premarket Notification Submission; 2) Recommendations for the Use of Clinical Data in Premarket Notification Submissions; and 3) Evidentiary Expectations for 510(k) Implant Devices.
On...