FDA publishes a guidance on 510(k) submissions for computer-assisted detection devices applied to radiology images and device data.
FDA issues a revised final guidance entitled Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiol...
FDA releases the form FDA-483 with five observations from an inspection at the Ripley, MS-based Delta Pharma outsourcing facility.
FDA publishes a draft guidance on the required electronic format for submission of over-the-counter monographs.
FDA updates its Covid-19 test policy to send more tests through the traditional review pathways and away from emergency use authorizations.
Federal Register notice: FDA modifies the organizational structure of the Office of Regulatory Affairs and field offices.
FDA publishes a guidance explaining the scope of its oversight of clinical decision support software in light of changes mandated by the 21st Century ...
FDA warns Chinas Zhejiang Tianyu Pharmaceutical Co. about CGMP deviations in the production of active pharmaceutical ingredients.
