DESIGN VERIFICATION/VALIDATION GUIDANCE, FOUR OTHERS UNDER CONSIDERATION BY FDA; AGENCY TO TAKE "CAUTIOUS" APPROACH TO DESIGN CONTROL ENFORCEMENT AFTER JUNE 1
This article was originally published in The Gray Sheet
Executive Summary
Additional guidance on design verification/validation may be developed by FDA to give device manufacturers added direction on complying with design control requirements under the quality system regulation, agency staffers indicated at a Feb. 2 meeting at the National Institutes of Health campus in Bethesda, Maryland.