Revised GMP reg's effective date to be delayed until mid-1998 to conform to EU deadline.
This article was originally published in The Gray Sheet
Executive Summary
REVISED GMP RULE EFFECTIVE DATE OF MID-1998 will be included in the final rule modifying FDA's device good manufacturing practices requirements. The design control provisions of the upcoming reg harmonize device GMPs with European quality systems requirements, and FDA wants to align the effective date of its rule with the June 1998 date at which QS requirements take effect for most products through the medical devices directive.