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FDA Makes Quality the Rule (continued)

An MD&DI January 1997 Feature Article

As mentioned above, FDA has changed the title of its revised regulation from "Good Manufacturing Practice for Medical Devices" to "Quality System Regulation." This change is more than just a matter of nomenclature; it is intended to reflect the expanded scope of the new regulation as well as to bring its terminology into harmony with that of the ISO 9000 family of quality systems standards. While the 1978 GMP regulation focused almost exclusively on production practices, the new regulation encompasses quality system requirements that apply to the entire life cycle of a device. The new rule is therefore properly referred to as a quality system regulation, into which the agency's revised requirements for good manufacturing practices have been incorporated.

Scope (820.1). The 1978 GMP regulation was a two-tier regulation that included general requirements applicable to all devices and additional requirements that applied only to critical ones. In the new quality system regulation, the notion of a critical device has been removed, and the term is no longer used. However, the new regulation's section on traceability (820.65) makes use of the same general concept, and the definition of traceable device found there is the same as the definition of critical device as presented in the 1978 GMP regulation (820.3(f)). Other critical-device requirements of the 1978 GMP regulation have been melded into appropriate sections of the quality system regulation; for instance, the critical operation requirements are now included in the section on process validation (820.75).

The new regulation's section on scope makes it clear that manufacturers need only comply with those parts of the regulation that apply to them. Thus, for example, only manufacturers who service devices need comply with the servicing requirements. Like the 1978 GMP regulation, the quality system regulation does not apply to component manufacturers, but they are encouraged to use it as guidance.

One important statement in the new regulation's section on scope is the definition of the phrase where appropriate, which is used in reference to a number of requirements. Contrary to what manufacturers might hope, this phrase doesn't limit application of the regulation's requirements to times when manufacturers believe they are appropriate. Instead, FDA means that a requirement should be considered appropriate "if nonimplementation could reasonably be expected to result in the product not meeting its specified requirements or the manufacturer not being able to carry out any necessary corrective action." In short, a requirement is considered appropriate unless the manufacturer can document justification to the contrary. Unfortunately, industry was not provided an opportunity to comment on the agency's use of this phrase.

Another important issue covered under the scope of the new regulation relates to foreign firms that export devices to the United States. The agency has routinely inspected such firms to determine whether they are complying with GMPs although it has no authority to do so, and must rely on an invitation from the company in question. Some foreign manufacturers have refused to allow FDA to inspect their facilities. The new regulation's section on scope addresses this situation by stating that devices produced by foreign manufacturers that refuse to permit FDA inspections will be considered adulterated and will be detained by U.S. customs. FDA is basing its authority to impose this penalty on the Federal Food, Drug, and Cosmetic Act (section 801(a)). It will be interesting to see what results if a foreign manufacturer chooses to challenge this position.

Definitions (820.3). The definitions of five terms used in the 1978 GMP regulation (critical component, critical process, critical device, noncritical device, and quality assurance) have been deleted from the new regulation. All the definitions that remain from the earlier regulation have been modified. At the same time, the quality system regulation includes definitions for 20 new terms. Some of these changes and additions are significant. Complaint (820.3(b)). According to the definition of this term, an allegation of deficiencies must be made before a device- related incident may be termed a complaint. This provision should serve as a check against those FDA investigators who have asserted that all service requests constitute complaints. All other incidents must be processed under the section on corrective action (820.100). The definition also makes it clear that complaints can only occur after a device has been distributed.

Establish (820.3(k)). This term occurs throughout the regulation. Wherever it occurs, manufacturers should understand that they are to define, document, and implement a program or system appropriate to meet the requirements under discussion. Documentation may be in paper or electronic format.

Product (820.3(r)). The definition of product includes manufacturing materials and components as well as in-process and finished components and devices, and returned devices.

Quality System (820.5). As stated in the section on scope, the new regulation now requires device manufacturers to establish a quality system, which is a much larger undertaking than the quality assurance program required by the 1978 GMP regulation. Therefore the term quality assurance no longer appears in the regulation.





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