Sharps destruction devices
This article was originally published in The Gray Sheet
Executive Summary
Studies to validate cleaning and decontamination procedures after each use should be conducted by manufacturers of the devices, according to a March 2 final guidance on PMA requirements. Needle destruction devices are among six Class III devices on FDA's list of commonly reprocessed single use devices for which PMAs must be submitted (1"The Gray Sheet" Feb. 5, 2001, p. 19). The guidance supersedes a February 1997 draft