JD Supra

Awash in Data? FDA Removes a Barrier in Real-World Evidence Generation

On December 15, 2025, the US Food and Drug Administration (FDA) issued a press release announcing that FDA eliminated a major ...
FierceBiotech

FDA opens door to massive real-world datasets in medical device submissions

The FDA said it plans to accept new forms of real-world evidence in product applications, starting with a subset of medical device submissions. The agency said the policy change aims to enable the use ...
Becker's Hospital Review

FDA loosens data rules for select medical device submissions

The FDA has eliminated a key barrier to the use of real-world evidence in certain medical device applications. Under new guidance issued Dec. 15, the agency said it will accept real-world evidence ...
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 ...
JD Supra

FDA medical device inspections in 2025: What we're seeing, what we expected, and why you need the right expertise now

After a quiet January marked by administrative transition and internal upheaval at FDA, enforcement activity has accelerated sharply in 2025. No warning letters were issued in the first month of the ...
MD&M East

FDA Removes Medical Device Application Review Barrier

FDA has removed a limitation that prevented real-world evidence to be used in drug and device applications reviews unless identifiable individual patient data was also collected. Now, the agency will ...
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 ...