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 ...
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 ...
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, ...
Forbes

FDA Medical Device Cybersecurity And SBOMs: Compliance And Potential

When the Federal Drug Administration (FDA) updated the provisions for medical device cybersecurity, one of those required the development of a software bill of materials (SBOM). It’s now mandatory for ...
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 ...
Forbes

FDA Medical Device Security SBOMs: While Great, Don’t Rely On Them Alone

The latest update to the Federal Drug Administration (FDA) for medical device cybersecurity mandates the development of a software bill of materials (SBOM). This provision can be a significant ...