In Brief: Nomination of device standards
This article was originally published in The Gray Sheet
Executive Summary
Nomination of device standards: FDA will "make every effort" to consider for its Aug. 15 recognized standards update any industry nominations submitted by June 15, device center Director Bruce Burlington says March 16 at the Health Industry Manufacturers Association annual meeting. The agency previously has said that nominations would have to be received by April 15 in order to be considered ("The Gray Sheet" March 9, p. 4). CDRH posts on its homepage (www.fda.gov/cdrh) a list of the minimum information needed to be included in a recommendation...