FDA clears a Fuse Medical 510(k) for its Tibial Revision Knee System and the PS Plus Posterior Stabilized Tibial Insert.
FDA releases an FDA-483 with 10 observations from an inspection at the Fujifilm Diosynth Biotechnologies drug substance manufacturing facility.
FDA issues a Warning Letter to Invisi Smart Technologies (United Kingdom) over its Invisi Smart Mask for sale in the U.S. without a cleared 510(k).
Amneal Pharmaceuticals says it will file an NDA for IPX-203 in mid-2022, after reporting positive topline results from a Phase 3 clinical trial that e...
Federal Register notice: FDA announces that beginning 3/1/2022 it will reject Electronic Common Technical Document submissions that fail validations 1...
Federal Register notice: FDA seeks comments on an information collection extension entitled Environmental Impact Considerations (OMB Control Number 09...
Baxter says it expects to deploy a software upgrade for its Spectrum IQ infusion pumps in the fourth quarter to address an issue experienced by some c...
FDA announces a 10/14 virtual public workshop on improving transparency of artificial intelligence/machine learning-enabled medical devices by enhanci...