Federal Register notice: FDA makes available additional draft and revised draft product-specific guidances that provide bioequivalence study design re...
Federal Register notice: FDA makes available a final guidance on Testing and labeling medical devices as MRI-safe.
CDRH announces research efforts it will undertake to address scientific knowledge gaps in host responses to an implanted metal device, including adver...
FDA approves a Janssen Pharmaceutical NDA for Rybrevant (amivantamab-vmjw) for treating adult patients with non-small cell lung cancer whose tumors ha...
Boston Scientific recalls its VICI SDS and RDS Venous Stent Systems after receiving reports indicating the devices may migrate or move from where they...
Federal Register notice: FDA makes available a final guidance on premarket submissions for peripheral vascular atherectomy devices.
Federal Register notice: FDA makes available a draft guidance to help implement the ICH Q12: document on postapproval changes.
FDA clears an Overjet 510(k) for its Overjet Dental Assist artificial intelligence product that performs measurement for treating periodontal disease.