FDA May Use ‘Real-World’ Data to Approve New Devices

Efforts to bring new medical devices to patients more quickly by stepping outside of the traditional, controlled study environment moved forward at the FDA with the release of two guidance documents.

The Food and Drug Administration released final guidance on adaptive designs for medical device clinical studies on the same day it issued draft guidance on the use of real-world evidence in evaluating medical devices. Notices announcing both documents were published in the July 27 Federal Register.

The guidance documents represent a departure from reliance on the randomized controlled clinical trial, which has long been considered the gold standard ...