FDA approves a Simplify Medical PMA for its Simplify Artificial Disc for one-level disc replacement indications.
Becton, Dickinson says four previously announced recalls of its BD Alaris System have been classified as Class 1 for three events and Class 2 for the ...
CDRH updates its public Manufacturer and User Facility Device Experience database to improve transparency and analysis of medical device report data.
FDA Review posts the Federal Register notice for the week ending 9/18/2020.
Federal Register notice: FDA sends to OMB a proposed information collection entitled Assessment of Terms and Phrases Commonly Used in Prescription Dru...
Federal Register notice: FDA seeks comments on a proposed study entitled Medical Conference Attendees Observations About Prescription Drug Promotion....
Federal Register notice: FDA seeks comments on a proposed Survey of Drug Product Manufacturing, Processing and Packing Facilities 21 CFR parts 210 an...