FDA recommends moving away from using duodenoscopes with fixed endcaps due to challenges cleaning them for reuse and persistent high contamination levels.
The FDA’s quest to modernize medical device reviews could require manufacturers to rethink their regulatory strategy in getting products through the agency.
The agency believes that additional changes are needed to fully modernize the 510(k) program.
Scott Gottlieb, M.D. & Jeff Shuren, M.D.;, Commissioner & Director of the Center for Devices and Radiological Health; U.S. Food and Drug Administration04.30.19
The agency will work to ensure safe and effective sterilization amid the shutdown of a large contract sterilization facility and the planned shutdown of another.
The 510(k) program must keep pace with the important innovations FDA is seeing in device development.
Scott Gottlieb, M.D., Commissioner; Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health;, U.S. Food and Drug Administration01.23.19
The agency aims to enhance medical device safety net and focus on several women's health devices.
Scott Gottlieb M.D., Commissioner; Jeff Shuren M.D., Director of the Center for Devices and Radiological Health, U.S. Food and Drug Administration11.21.18
Since the Cures Act was passed, CDRH has granted 54 devices breakthrough status.
Malvina Eydelman, M.D., Director, Division of Ophthalmic, and Ear, Nose, and Throat Devices, Office of Device Evaluation, Center for Devices and Radiological Health02.28.18