Federal Register notice: FDA makes available a draft guidance entitled Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submis...
Federal Register notice: FDA makes available a draft guidance entitled Evaluation of Thermal Effects of Medical Devices That Produce Tissue Heating an...
Federal Register notice: FDA amends certain medical device regulations to update a citation for information collection and conform the regulatory prov...
FDA publishes a draft guidance on the information that should be in medical device premarket submissions to support an evaluation of the devices therm...
FDA publishes for comment an updated draft guidance on requesting feedback and meetings with FDA on medical device submissions.
Four stakeholders suggest ways for FDA to improve its draft guidance on advanced manufacturing technologies designation.
FDA grants Poseida Therapeutics an orphan drug designation for its P-BCMA-ALLO1, a novel BCMA-targeted allogeneic, T stem cell memory-rich chimeric an...
FDA clears an Ortho Development 510(k) for its Trivicta Hip System, a triple-taper femoral stem that is intended to facilitate an optimal fit within t...
