Revised biocompatibility guidance to be completed by late summer, FDAers estimate.
This article was originally published in The Gray Sheet
Executive Summary
REVISED FDA BIOCOMPATIBILITY GUIDANCE TO BE COMPLETED BY LATE SUMMER, agency staffers predict. The guidance, which is expected to reduce device laboratory testing requirements, "should be off the press shortly," Mel Stratmeyer, Director of the Health Sciences Branch in the FDA device center's Office of Science and Technology, said June 2 at the Medical Design and Manufacturing East conference in New York City.