Becker's Hospital Review

FDA loosens data rules for select medical device submissions

FDA loosens data rules for medical devices by allowing real-world evidence without patient identifiers in marketing submissions.
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 ...
Medical Device and Diagnostic Industry (MD+DI)

FDA Removes Medical Device Application Review Barrier

FDA is removing barriers to real-world evidence in device applications, allowing the use of de-identified patient data from ...
Medical Design & Outsourcing

FDA eliminates real-world evidence barrier in medical device reviews

The FDA announced that it removed a limitation on the use of real-world evidence (RWE) in drug and device application reviews ...
STAT

Key digital health and device leaders depart FDA

Neuralink, Elon Musk’s frothy brain-computer interface company, poached David McMullen, director of FDA’s office of ...
BioWorld

FDA eyes less restrictive approach to RWE in regulatory decisions

The U.S. FDA announced Dec. 15 that it will take a more relaxed approach regarding the use of real-world evidence (RWE) in ...
MedTech Dive

FDA gets mixed feedback on performance monitoring for AI

Medtech industry groups said the FDA should use existing regulatory and quality tools to monitor performance, while medical ...
Fierce Biotech

GAO probe finds understaffed FDA putting some medical device recall work on the 'back burner'

The FDA’s oversight of medical device recalls continues to be plagued by staffing challenges—forcing some activities to be ...