FDA Review posts the Federal Register notices for the week ending 2/21/2021.
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Federal Register notice: FDA makes available a draft guidance to help implement the ICH Q12: document on postapproval changes.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.
FDA accepts for priority review a BeiGene supplemental NDA for Brukinsa (zanubrutinib) for treating adult patients with marginal zone lymphoma.
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...