This article was originally published in The Gray Sheet
CDRH-developed CD-ROM, "An Overview of the Regulatory Requirements for Reprocessing of Single-Use Devices by Hospitals," will be made available at no charge while supplies last. The two-disc set includes coverage of SUD reprocessing, registration and listing, premarket review, labeling, corrections and removals, tracking and QSR problems. Interested parties should complete an online form at the device center's 1reuse website...
You may also be interested in...
Assessment work also isn’t slowing down, the new and generic drug office directors said in an interview, but approval data offers a note of concern.
Abbott is launching a second test to detect COVID-19. The diagnostics giant announced on 27 March the release of a rapid, point-of-care test that can deliver results within five minutes.
President Trump on 27 March finally pulled the trigger on using his powers under the Defense Production Act, forcing General Motors Co. to manufacture medical ventilators. The only thing is, GM is already doing that.