In Brief: Device corrections and removals reg
This article was originally published in The Gray Sheet
Executive Summary
Device corrections and removals reg: Effective date of the regulation will be stayed indefinitely pending Office of Management and Budget completion of the information collection requirements, FDA says in a Dec. 24 Federal Register notice. The reg, which requires manufacturers to report device recalls to FDA ("The Gray Sheet" May 26, p. 8), originally was slated to go into effect Nov. 17...