FDA clears a TransEnterix 510(k) for the Intelligent Surgical Unit (ISU) that enables machine vision capabilities on the Senhance Surgical System.
Federal Register notice: FDA announces a 4/16 Circulatory System Devices Panel of the Medical Devices Advisory Committee meeting that will review the ...
Federal Register notice: FDA makes available a final guidance entitled Biological Product Deviation Reporting for Blood and Plasma Establishments.
Federal Register notice: FDA sends to OMB an proposed information collection entitled Requests for Nonbinding Feedback After Certain FDA Inspections o...
FDA issues Roche Molecular Systems an emergency use authorization for its cobas SARS-CoV-2 test for diagnosing coronavirus (COVID-19).
FDA releases the FDA-483 with nine observations from an inspection at Fusion IV Pharmaceuticals.
FDA finalizes a guidance on Competitive Generic Therapies which describes the process that generic drug applicants should follow to request designatio...
FDA asks and answers frequently asked questions about Covid-19 independent lab tests under the agencys new immediately-in-effect guidance.