Hospital bed guidance comments
This article was originally published in The Gray Sheet
Executive Summary
FDA opts not to extend its Nov. 29 deadline for comments on its draft guidance "Hospital Bed System Dimensional Guidance to Reduce Entrapment," but asserts that if AdvaMed submits comments within 30 days of the deadline, they still will be considered in the preparation of the final guidance. AdvaMed had requested a 30-day extension Nov. 18 due to the high volume of input the trade organization received from member firms. FDA's Nov. 22 response asserts that a formal extension "is not necessary." The agency issued the draft guidance on Aug. 30, based on recommendations from a Hospital Bed Safety Workgroup (1"The Gray Sheet" Sept. 6, 2004, p. 21)...