FDA and HHS’ action to reverse HHS’ last minute 510 (k) exemptions may portend similar actions in the coming weeks or months, particularly where HHS appears to have acted without consulting FDA.

On April 16, the U.S. Department of Health and Human Services (HHS) and Food and Drug Administration (FDA) published a notice of withdrawal of their January 15 proposal to exempt 84 medical device ...

Some say it’s not what you say but how you say it, but the U.S. FDA’s Feb. 10, 2025, warning letter to Denver-based Exer Labs Inc., makes clear that a 510(k)-exempt device can’t be altered and ...