FDA issues a guidance on electronic formats for medical device regulatory submissions.
Federal Register notice: FDA announces the revocation of an Emergency Use Authorization issued to Chembio Diagnostic Systems for the DPP Covid19 IgM/I...
Federal Register notice: FDA makes available a draft guidance entitled Select Updates for Guidance for the Non-Clinical and Clinical Investigation of ...
Federal Register notice: FDA announces its support for the current version of Clinical Data Interchange Standards Consortium Standard for the Exchange...
FDA issues a guidance recommending ways to comply with the clinical testing special control for 510(k)s for prostate ablation high-intensity ultrasoun...
Federal Register notice: FDA makes information available on the issuance and reissuance of Emergency Use Authorizations for certain medical devices re...
FDA releases its latest batch of Warning Letters that includes one medical product company Kegan Wellness.
FDA commissioner Stephen Hahn says in a CTAP update that FDA has reviewed over 230 trials for Covid therapeutics.