One day this summer, Pat McAfee, the former NFL punter turned ESPN personality, interviewed New York Jets cornerback Sauce Gardner about his partnership with Q-Collar, the only medical device cleared ...
FDA is removing barriers to real-world evidence in device applications, allowing the use of de-identified patient data from ...
Medical Device Network on MSN
FDA removes patient-identifiable RWE requirement for device submissions
The FDA’s change opens the door for RWE gleaned from de-identified data sources to be used for device submissions to the agency.
15don MSN
The FDA rarely forces manufacturers to recall dangerous medical devices, watchdog report finds
The Food and Drug Administration rarely uses its authority to pull dangerous medical devices off the market and is so poorly ...
On July 14, 2025, FDA issued a warning letter to WHOOP, Inc., notifying the company that its marketing of Blood Pressure Insights (BPI) was neither cleared nor approved. FDA stated that BPI qualifies ...
FDA's challenges — such as insufficient staffing — can create inefficiencies in the process and potentially put lives at risk,” the U.S. Government Accountability Office said.
The FDA recently had a meeting to explore regulatory aspects of AI-enabled mental health medical devices. I explore a useful ...
The FDA’s oversight of medical device recalls continues to be plagued by staffing challenges—forcing some activities to be placed on the “back burner” and resulting in lengthy response times, ...
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 ...
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