FDA
The Food and Drugs Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published detailed guidance dedicated to the eSTAR Pilot Program, which is a part of the 510(k) Program Pilots together with the 510(k) Review...
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published a final rule on medical device classification. The appropriate notice of the amendment to the medical device classification regulations...
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published a guidance document dedicated to acceptance and filing reviews for premarket approval applications (PMAs). The present document...
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has announced regulatory flexibilities for certain medical devices. The appropriate notice has been published on the official website of the Federal...
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published a guidance document dedicated to the specific criteria applied by the Agency when determining whether a 510(k) Premarket Notification...
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has developed a guidance document dedicated to Pre-Requests for Designation (Pre-RFD). The document describes the approach to be applied by...
