History of the Quality System

The Quality System regulation, which was published by FDA as a final rule on October 7, 1996, revises the 1978 medical device GMP regulation. The Quality System regulation replaces quality assurance (QA) program requirements with Quality System requirements that include new provisions concerning the design, purchasing, and servicing of medical devices. The current regulation also codifies FDA’s interpretation of the 1978 GMP regulation with regard to record-keeping requirements for device failure and complaint investigations. It also clarifies the requirements for process validation, product change control, and collection and evaluation of quality data. As part of the revision process, FDA has attempted to harmonize the Quality System regulation with International Organization for Standardization (ISO) 13485, the Quality Management System (QMS) standard for medical device manufacturers.

Historical Perspective: The 1978 GMP Regulation

The GMP requirements for medical devices (21 CFR Part 820) were authorized by the Medical Device Amendments of 1976, which are found in section 520(f) of the FD&C Act (21 USC 360j(f)). In response to the new authority provided by section 520(f), FDA issued final regulations in the Federal Register of July 21, 1978 (43 FR 31508), prescribing GMP requirements for the methods used in — and the facilities and controls used for — the manufacture, packing, storage, and installation of medical devices. This regulation became effective on December 18, 1978, and was codified under part 820.

In drafting the 1978 regulation, FDA recognized that the medical device industry consists of manufacturers whose devices and manufacturing processes differ significantly. Therefore, the GMP regulation was designed to specify general requirements in areas of concern that applied to all medical device manufacturers, as well as additional requirements for high-risk devices, which were termed “critical devices.” This two-tier approach was intended to prevent excessive regulation of the medical device industry. Each manufacturer was expected to supply the details of an appropriate GMP program by developing for the manufacture of each device a detailed set of procedures implementing the GMP regulation. FDA would then examine these procedures to determine whether a manufacturer was complying with the regulation. This flexible, umbrella GMP philosophy is carried over into the current Quality System regulation.

The GMP Revision Process

Until the promulgation of the Quality System regulation, the medical device GMP requirements had not been revised since 1978, except for editorial changes to update organizational references and revisions to the list of critical devices that were included in the Preamble to the 1978 regulation. The Quality System regulation is the result of a revision effort begun in 1990.

An advance notice of proposed rulemaking appeared in the Federal Register on June 15, 1990. This notice announced FDA’s intent to revise the GMP regulation. Because several studies and recall evaluations indicated that a significant number of medical device failures were caused by design defects, FDA began promoting the addition of design controls to the GMP regulation. In response, the industry took a common position that FDA did not have the authority to add design controls to the regulation.

This difference of opinion between FDA and the industry became a non-issue on November 28, 1990, when Congress passed the Safe Medical Devices Act of 1990 (SMDA). The SMDA amended section 520(f) of the FD&C Act, providing FDA with the authority to add preproduction design controls to the GMP regulation. On November 30, 1990, a notice of availability of an information document intended to facilitate changes to the cGMP was printed in the Federal Register. Subsequently, FDA’s Device Good Manufacturing Practice advisory committee held a public meeting in May 1991 to solicit comments and discuss the proposed changes to the regulation.

SMDA also included a new section 803, which encouraged FDA to work with foreign countries toward mutual recognition of GMP and other regulations. FDA had already been working for a number of years with the European Community, Australia, Canada, and Japan in an effort to harmonize requirements. The revision of the GMP regulation, including the design controls authorized by the SMDA, allowed the regulation to be consistent, where feasible, with the requirements contained in applicable international standards, specifically ISO 9001:1994, Quality systems—Model for Quality Assurance in Design, Development, Production, Installation, and Servicing, and ISO 13485:1996, Quality systems—Medical devices—Particular requirements for the application of ISO 9001.

The first proposed rule revising the GMP requirements was published in the November 23, 1993 issue of the Federal Register. This proposal consisted of the ISO requirements plus those requirements of the 1978 regulation that were not part of ISO 9001. Approximately 280 individuals and groups commented on the proposal.

FDA announced a second proposal in July 1995, as “Notice of Availability of a Working Draft of the CGMP Final Rule.” Approximately 175 individuals and groups commented on the draft. Shortly after the release of the July 1995 Working Draft, FDA held an open public meeting and a GMP Advisory Committee meeting to solicit public comment.

The Final Rule of the Quality System regulation, published on October 7, 1996, includes in its Preamble FDA’s responses to 204 summarized industry comments on the 1995 Working Draft. These comments provide insight into FDA’s perspective on quality systems and its regulatory objectives for medical device manufacturers.

The Differences Between the 1978 GMP and the Quality System Regulation

As mentioned previously, the 1978 GMP regulation imposed additional requirements on “critical devices,” which were defined as devices that are intended for surgical implantation into the body, or devices that are intended to support or sustain life, and whose failure to perform when properly used according to the labeling, can reasonably be expected to result in significant injury to the user. The term “critical device” has been eliminated in the Quality System regulation. However, the regulation still allows manufacturers the flexibility to determine the amount or degree of action necessary, commensurate with the risk associated with the finished device.

The Quality System regulation incorporates new requirements for preproduction design control and supplier control. Servicing controls for manufacturers also have been added. Although it was inherent in the 1978 GMP regulation, specific language formanagement responsibilities, process validation, corrective and preventive action, Quality System Records (QSRs), and statistical techniques is explicit in the Quality System regulation.

Source: Pelnik, T.M. (ed.), The Quality System Compendium: GMP Requirements and Industry Practice, 2ed. 2007, Association for the Advancement of Medical Instrumentation, 253 pp.

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