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Key words: design control, quality system, harmonization
FY 96 saw the culmination of a multi-year Center initiative to restructure the Current Good Manufacturing Practices (CGMPs). The CGMP regulation has been substantially rewritten along the lines of the ubiquitous international quality systems standard, ISO 9001, and henceforth will be called the Quality Systems Regulation.
Historically, studies have shown that many medical device defects have their roots in poor design rather than manufacturing shortcomings. The Medical Electronics Branch (MEB) has long been at the forefront of efforts to focus regulatory attention on design issues in electronic medical systems and medical device software. These efforts have been constrained by a limited complement of weapons in the Agency's regulatory arsenal. Design controls, a new authority that CDRH received as a result of the Safe Medical Device Act of 1990, provide a sound legislative basis for focusing on design issues. While much of the language of the new Quality Systems Regulation is evolutionary in nature, the new design control section of the regulation represents a revolutionary change in the status quo. Industry has been largely supportive of the design controls effort, because the benefits to manufacturers as well as users and patients are well documented.
MEB had the lead in developing guidance to assist manufacturers in the establishing and implementing controls necessary to assure compliance with the new design control requirements. In March 1996, a copy of the Design Control Guidance Document was released in draft form for public review. Subsequently, public comments were collected and reviewed by a Center-wide team led by MEB staff, and the document was substantially rewritten. The guidance interprets the language of the regulation in practical terms, describes the underlying principles of design control, and illustrates the application of design controls in a variety of real-world situations. The document has been reviewed by Study Group 3 of the Global Harmonization Task Force with the hope that it might be used by other regulatory bodies around the world. It is scheduled for publication early in calendar year 1997.
MEB will continue to develop guidance for system and software safety and dependability. OST has the lead in coordinating the development of guidance for other assurance technologies such as human factors engineering. [Enf, PostMS]