The "Intro to Medical Device Submission - 510(k)s, PMAs & Exemptions (Oct 9, 2025)" training has been added to ResearchAndMarkets.com's offering. The regulation and control of new or substantially ...
Yesterday, the FDA announced in a press release that it is eyeing potential updates to the agency’s 510(k) clearance pathway for medical devices. These could include a requirement for more modern ...
Today, Harrison.ai submitted a Citizen Petition asking the Food and Drug Administration (FDA) to create a streamlined pathway to market for certain AI-powered radiology diagnostic devices. Under the ...
As of tomorrow, individual genetic risk tests are officially exempt from requiring 510(k) premarket approval, provided the company offering the test has gone through a one-time premarket review of its ...
The landscape of FDA medical device regulation has undergone a significant transformation. Today's regulatory environment presents both familiar challenges and entirely new complexities that 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 ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results
Feedback