Regulatory & Quality

FDA Makes Quality the Rule

January 1, 1997

2 Min Read

An MD&DI January 1997 Feature Article

QUALITY

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 itsmedical device goodmanufacturing practices (GMP) regulation in the Federal Register.¹Manufacturers that have not remained current with the changes in the regulationthat the agency has proposed over the past six years are in for a majorsurprise. And even those that have kept current with the agency's proposals upthrough the working draft of July 1995 will find a few new twists.

Now renamed as a quality system regulation, FDA's new revision differssignificantly from the previous GMP regulation of 1978.² It alsoadds a number of requirements not present in the agency's proposed rule ofNovember 1993, and introduces a number of changes developed since publication ofthe July 1995 working draft.^3,4 Specifically, the new quality systemregulation 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 ofthe Global Harmonization Task Force.⁵ In slightly different wording,the regulation now incorporates all the requirements ofISO 9001, the fullest ofthe quality systems standards compiled by the InternationalOrganization for Standardization (ISO).⁶ For example, there arenow requirements for quality planning, for a quality manual, and for an outlineof the general quality procedure. All these new requirements were added in orderto bring the regulation into harmony with the quality systems standardscurrently accepted in the member nations of the European Union (EU), and thereis certainly a benefit to their inclusion in the new regulation.

But the regulation also adds documentation requirements that would not have beenincluded if harmonization were not an agency goal, and these requirements mustnow be met by all U.S. device manufacturers--even if they do not intend toexport to the EU. On the up side, the language of the new regulation will allowmanufacturers much more flexibility than either the November 1993 proposal orJuly 1995 working draft would have allowed. In the pages that follow, thisarticle will review the changes that the agency has incorporated into thesections of its newest regulation and will discuss how those changes are likelyto affect device manufacturers.

GENERAL PROVISIONS

QUALITY SYSTEM REQUIREMENTS

DESIGN CONTROLS

REFERENCES