FDA posts a final guidance entitled Enforcement Policy for Clinical Electronic Thermometers.
Federal Register notice: FDA makes available a final guidance entitled Enforcement Policy for Certain Supplements for Approved Premarket Approval (PMA...
The attorneys general from 25 states list six things FDA should do immediately to address the concern that pulse oximeters are not calibrated to work ...
CDRH asks for public comments on several questions to help it advance the development of digital health technologies for use in diabetes diagnosis.
FDA approves Abbotts Alinity m molecular human papillomavirus (HPV) diagnostic test.
FDA researchers look at manufacturing changes and comparability assessment of FDA-approved monoclonal antibodies and Fc-fusion products.
FDA grants I-Mab a breakthrough therapy designation for felzartamab, an investigational CD38 antibody for treating primary membranous nephropathy.
FDA says it will continue to exercise enforcement discretion for some supplements to PMAs and HDEs.
