The Center for Devices and Radiological Health said it is on track to meet review times specified by user fee agreements, ...
The Food and Drug Administration's headquarters is in Silver Spring, Maryland. This story was originally published on MedTech Dive. To receive daily news and insights, subscribe to our free daily ...
Keeping up with medical device news today can feel like a full-time job. New gadgets, new rules, and big company moves happen ...
ARLINGTON, Va.--(BUSINESS WIRE)--The Medical Device Innovation Consortium (MDIC), the first public-private partnership created with the sole objective of advancing medical device regulatory science, ...
The Food and Drug Administration (FDA) has begun 2026 with a clear signal to the direct‑to‑consumer testing industry: self‑collection devices ...
In 2025, the U.S. Food and Drug Administration (FDA or the Agency) issued a surprising number of enforcement letters to manufacturers, as well ...