The Elena and Miles Zaremski Law Medicine Forum presents: Medical Device Regulation: Going from Bad to Worse...or Better? with George Horvath Innovations in medical device technology hold the ...
The FDA’s oversight of medical device recalls continues to be plagued by staffing challenges—forcing some activities to be ...
Neuralink, Elon Musk’s frothy brain-computer interface company, poached David McMullen, director of FDA’s office of ...
The "Navigating EU (European Union) and FDA (Food and Drug Administration) Regulations for Drug/Device and Device/Drug Combination Products Training Course (Mar 2nd - Mar 3rd, 2026)" training has been ...
A federal judge in Texas has blocked the FDA’s plans to bring laboratory-developed tests under the same regulations it uses to oversee other in vitro diagnostics and medical devices—saying the agency ...
The medical device industry is undergoing a significant transformation as FDA transitions from the longstanding Quality System Regulation (QSR) to the Quality Management System Regulation (QMSR), ...
An Instagram ad catches your eye. You click to the product’s website and find reassurance: The product, it says, is "FDA certified" or was "produced in an FDA registered facility." Mention of the U.S.
The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...
SAN ANTONIO--(BUSINESS WIRE)--The U.S. Food and Drug Administration (“FDA”) has granted Xenex Disinfection Services, Inc. (“Xenex”) De Novo authorization for the company’s LightStrike TM + device, a ...
The FDA recently had a meeting to explore regulatory aspects of AI-enabled mental health medical devices. I explore a useful ...
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