Single-use devices
This article was originally published in The Gray Sheet
Executive Summary
As of Aug. 14, all reprocessors of single-use devices (SUDs) who fail to comply with premarket and non-premarket requirements could face FDA enforcement action. Non-premarket requirements include items such as registration and listing, medical device reporting, tracking, corrections and removals, quality systems regulations and labeling. Last February, FDA granted third party reprocessors who had submitted 510(k)s a six-month grace period in which to obtain clearance for SUDs (11"The Gray Sheet" Feb. 18, 2002, p. 5). Also expired as of Aug. 14 is the grace period allowing hospitals reprocessing SUDs one extra year to come into compliance with postmarket requirements...