FDA Updates Standards for Medical Device Evidence
December 18, 2025
December 18, 2025
WASHINGTON, Dec. 18 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration has issued a finalized guidance document outlining how data gathered from routine healthcare settings can support the regulatory review of medical devices.
The document clarifies the criteria used to evaluate the quality of information generated outside of traditional clinical trials.
The filing centers on the use of real-world data to create evidence for regulat . . .
The document clarifies the criteria used to evaluate the quality of information generated outside of traditional clinical trials.
The filing centers on the use of real-world data to create evidence for regulat . . .