An MD&DI January 1997 Feature Article
Part 1: FDA's final revision of the medical device GMP regulation brings U.S. manufacturing into line with international quality systems standards.
(Note: Part 2 of this article is now available on our Web site.)
On October 7, 1996, FDA published the long-awaited revision of its medical device good manufacturing practices (GMP) regulation in the Federal Register.1 Manufacturers that have not remained current with the changes in the regulation that the agency has proposed over the past six years are in for a major surprise. And even those that have kept current with the agency's proposals up through the working draft of July 1995 will find a few new twists.
Now renamed as a quality system regulation, FDA's new revision differs significantly from the previous GMP regulation of 1978.2 It also adds a number of requirements not present in the agency's proposed rule of November 1993, and introduces a number of changes developed since publication of the July 1995 working draft.3,4 Specifically, the new quality system regulation contains major additional requirements in the areas of design, management responsibility, purchasing, and servicing.
It is clear that the new regulation has been greatly influenced by the work of the Global Harmonization Task Force.5 In slightly different wording, the regulation now incorporates all the requirements of ISO 9001, the fullest of the quality systems standards compiled by the International Organization for Standardization (ISO).6 For example, there are now requirements for quality planning, for a quality manual, and for an outline of the general quality procedure. All these new requirements were added in order to bring the regulation into harmony with the quality systems standards currently accepted in the member nations of the European Union (EU), and there is certainly a benefit to their inclusion in the new regulation.
But the regulation also adds documentation requirements that would not have been included if harmonization were not an agency goal, and these requirements must now be met by all U.S. device manufacturers--even if they do not intend to export to the EU. On the up side, the language of the new regulation will allow manufacturers much more flexibility than either the November 1993 proposal or July 1995 working draft would have allowed. In the pages that follow, this article will review the changes that the agency has incorporated into the sections of its newest regulation and will discuss how those changes are likely to affect device manufacturers.