U.S. Food and Drug Administration

Happy 50th Anniversary, CDRH!

On May 28, 1976, the Medical Device Amendments were signed into law — a landmark moment that transformed how the United States regulates medical devices and protects patients while advancing innovation.

Before 1976, the FDA had limited authority over medical devices. The Medical Device Amendments changed everything by establishing a three-tier classification system (Class I, II, and III) for medical devices, creating the 510(k) and Premarket Approval (PMA) pathways, and empowering the FDA to ensure devices are safe and effective before they reach patients.

The Center for Devices and Radiological Health (CDRH), as we know it today, has worked tirelessly to bring safe, effective, and innovative medical devices to the patients who need them.

Fifty Years of the Medical Device Amendments. Fifty years of protecting patients. Fifty years of innovation.

Here's to the next 50!

https://www.fda.gov/news-events/fda-voices/fifty-years-medical-device-amendments-building-strong-foundation-advance-safe-effective-and-high

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