FDA Makes Quality the Rule (continued) 2524

An MD&DI January 1997 Feature Article

As mentioned above, FDA has changed the title of its revised regulation from "GoodManufacturing Practice for Medical Devices" to "Quality SystemRegulation." This change is more than just a matter of nomenclature; it isintended to reflect the expanded scope of the new regulation as well as tobring its terminology into harmony with that of the ISO 9000 family of qualitysystems standards. While the 1978 GMP regulation focused almost exclusively onproduction practices, the new regulation encompasses quality system requirementsthat apply to the entire life cycle of a device. The new rule is thereforeproperly referred to as a quality system regulation, into which the agency'srevised requirements for good manufacturing practices have been incorporated.

Scope (820.1). The 1978 GMP regulation was a two-tier regulation thatincluded general requirements applicable to all devices and additionalrequirements that applied only to critical ones. In the new quality systemregulation, the notion of a critical device has been removed, and the term is nolonger used. However, the new regulation's section on traceability (820.65)makes use of the same general concept, and the definition of traceable devicefound there is the same as the definition of critical device as presented in the1978 GMP regulation (820.3(f)). Other critical-device requirements of the 1978GMP regulation have been melded into appropriate sections of the quality systemregulation; for instance, the critical operation requirements are now includedin the section on process validation (820.75).

The new regulation's section on scope makes it clear that manufacturers needonly comply with those parts of the regulation that apply to them. Thus, forexample, only manufacturers who service devices need comply with the servicingrequirements. Like the 1978 GMP regulation, the quality system regulation doesnot apply to component manufacturers, but they are encouraged to use it asguidance.

One important statement in the new regulation's section on scope is thedefinition of the phrase where appropriate, which is used in referenceto a number of requirements. Contrary to what manufacturers might hope, thisphrase doesn't limit application of the regulation's requirements to times whenmanufacturers believe they are appropriate. Instead, FDA means that arequirement should be considered appropriate "if nonimplementation couldreasonably be expected to result in the product not meeting its specifiedrequirements or the manufacturer not being able to carry out any necessarycorrective action." In short, a requirement is considered appropriateunless the manufacturer can document justification to the contrary.Unfortunately, industry was not provided an opportunity to comment on theagency's use of this phrase.

Another important issue covered under the scope of the new regulation relates toforeign firms that export devices to the United States. The agency has routinelyinspected such firms to determine whether they are complying with GMPs althoughit has no authority to do so, and must rely on an invitation from the company inquestion. Some foreign manufacturers have refused to allow FDA to inspect theirfacilities. The new regulation's section on scope addresses this situation bystating that devices produced by foreign manufacturers that refuse to permit FDAinspections 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 ifa foreign manufacturer chooses to challenge this position.

Definitions (820.3). The definitions of five terms used in the 1978 GMPregulation (critical component, critical process, criticaldevice, noncritical device, and quality assurance) have beendeleted from the new regulation. All the definitions that remain from theearlier regulation have been modified. At the same time, the quality systemregulation includes definitions for 20 new terms. Some of these changes andadditions are significant. Complaint (820.3(b)). According to thedefinition of this term, an allegation of deficiencies must be made before adevice- related incident may be termed a complaint. This provision should serveas a check against those FDA investigators who have asserted that all servicerequests constitute complaints. All other incidents must be processed under thesection on corrective action (820.100). The definition also makes it clear thatcomplaints 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 requirementsunder discussion. Documentation may be in paper or electronic format.

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

Quality System (820.5). As stated in the section on scope, the newregulation now requires device manufacturers to establish a quality system,which is a much larger undertaking than the quality assurance program requiredby the 1978 GMP regulation. Therefore the term quality assurance nolonger appears in the regulation.

INTRODUCTION

QUALITY SYSTEM REQUIREMENTS

DESIGN CONTROLS

REFERENCES