In Brief: FDA's HACCP concept

FDA's HACCP concept: Agency proposal to implement a new inspection methodology based on hazard analysis critical control points is rejected by industry representatives at a Nov. 20 FDA/industry meeting in Washington, D.C. As proposed at the meeting, the program would have directed inspectors to examine critical points in the manufacturing process that would be more likely to result in device failures if deficient ("The Gray Sheet" May 19, p. 6). Reps from the Health Industry Manufacturers Association, the National Electrical Manufacturers Association and the Association of Medical Diagnostics Manufacturers dismissed the concept as being incompatible with quality system regulations, pointing out that too many device manufacturing procedures would constitute critical control points. The trade groups resolved to form a working group with FDA to examine different ways of reviewing FDA's compliance program guide with the aim of shortening inspections for all devices. The group's initial meeting is scheduled for January...