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 ...
Becker's Hospital Review

FDA Finalizes Medical Device ID Database Guidance

The Food and Drug Administration recently released finalized guidance for medical device labelers for submitting data to the Global Unique Device Identification Database. A draft version of the ...
FierceBiotech

FDA's novel medical device clearances slow to a crawl

According to the FDA’s public database, since the start of this year, the agency has issued only two de novo medical device clearances. That includes the Jan. 17 green light of Myocene’s neuromuscular ...
MD&M East

FDA Acknowledges New AAMI Standards for Medical Device Sterilization

FDA has amended its database of Recognized Consensus Standards to include revised versions of sterility assurance and sterilization documents previously recognized in December of 2024. The new entry ...
GlobalData on MSN

Nearly a third of FDA medical device adverse event reports filed late

Almost a third of medical device adverse events (AEs) were reported by manufacturers later than the US Food and Drug ...