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 ...
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 ...
The American Journal of Managed Care

FDA to Accept Deidentified Real-World Evidence for Select Medical Device Applications

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 ...
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 ...
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 ...
JD Supra

2025 Year in Review: FDA Drug and Device Advertising and Promotion Enforcement

In 2025, the U.S. Food and Drug Administration (FDA or the Agency) issued a surprising number of enforcement letters to ...