For decades, FDA’s Center for Devices and Radiological Health (CDRH) has been recognizing standards that can be referenced in premarket medical device submissions. Congress broadly directed federal ...

The Center for Devices and Radiological Health (CDRH), the US Food and Drug Administration's (FDA) medical device regulator, has announced that it plans to recognize five new standards maintained by ...

In comments to US Food and Drug Administration (FDA) February draft guidance, industry experts called on the agency for alignment of the approaches to voluntary consensus standards (VCS) recognition.

On March 15, 2024, FDA published a white paper titled “Artificial Intelligence & Medical Products: How CBER, CDER, CDRH, and OCP are Working Together” (the AI White Paper) on the use of artificial ...

The U.S. FDA’s emphasis on alternatives to ethylene oxide is gaining momentum with the help of internationally recognized standards — such as ISO 11737 — in a move that will enable a less cumbersome ...

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