DEVICE GMP DESIGN CONTROLS WILL BE ENFORCED IN JUNE 1998, 12 MONTHS AFTER RULE TAKES EFFECT, FDA's TRAUTMAN SAYS; THIRD-PARTY SERVICERS TO BE EXEMPT
This article was originally published in The Gray Sheet
Executive Summary
Design control requirements in FDA's revised medical device good manufacturing practice regulations will go into effect June 1, 1997, but manufacturers will have a one-year transition period during which design control violations will not be subject to enforcement actions, Kim Trautman, GMP/Quality Systems Expert in FDA's Center for Devices and Radiological Health, told participants at a Sept. 12 meeting in Rockville, Maryland.