Federal Register notice: FDA makes available a final guidance entitled “510(k) Third Party Review Program and Third-Party Emergency Use Authorization (EUA) Review.”
CDRH says a new device recall pilot program aims to improve communication timeliness about corrective actions being taken by companies on high-risk recall issues.
Federal Register notice: FDA makes available a final guidance entitled “510(k) Third Party Review Program and Third-Party Emergency Use Authorization (EUA) Review.”
CDRH says a new device recall pilot program aims to improve communication timeliness about corrective actions being taken by companies on high-risk recall issues.
Federal Register notice: FDA determines that Renew Pharmaceuticals’ IC-Green (indocyanine green) was not withdrawn from sale for reasons of safety or effectiveness.
FDA says MXBBB has recalled one lot of Umary hyaluronic acid caplets that contain undisclosed diclofenac and omeprazole.
