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 ...
MedPage Today

Goodbye FAERS? FDA Launches New Combined Adverse Event Database

The FDA has launched a new adverse event reporting system that will consolidate several systems it has for reporting different types of adverse events, the agency announced Wednesday. The new system, ...
MedTech Dive

FDA to unify agency’s ‘fragmented’ safety surveillance system

Combining the disparate databases used to detect potential issues with drugs, vaccines and other products into a single ...
STAT

FDA warns medical device makers about rise in fabricated data

An increasing number of medical device companies are submitting fabricated and unreliable data, the Food and Drug Administration noted Tuesday morning. The data comes from third-party labs hired by ...
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 ...
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 ...