FDA loosens data rules for medical devices by allowing real-world evidence without patient identifiers in marketing submissions.
The FDA announced that it removed a limitation on the use of real-world evidence (RWE) in drug and device application reviews ...
The FDA now accepts RWE for device submissions without needing identifiable patient data, facilitating the use of large, de-identified databases. This change addresses previous limitations that ...
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 US Food and Drug Administration (FDA) is removing a limitation on the use of real-world evidence (RWE), clearing the way ...
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 ...
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 ...
The agency in July warned WHOOP that its blood-pressure insights feature made the company's wearable product look more like a medical device as it estimated systolic and diastolic values used in ...
The FDA recently had a meeting to explore regulatory aspects of AI-enabled mental health medical devices. I explore a useful ...
FDA's challenges — such as insufficient staffing — can create inefficiencies in the process and potentially put lives at risk ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results
Feedback