Medical Device & Diagnostic Industry
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Originally published February 1996
Inspectional strategies for design control will be the focus of an ad hoc industry committee to be appointed by FDA later this year, according to Kimberly Trautman, acting director of the Cardiovascular/Neurology Branch in the Office of Compliance at the agency's Center for Devices and Radiological Health.
Many in industry have voiced concern that agency inspectors might use the design control requirements of FDA's proposed revision of the good manufacturing practices (GMP) regulation to carry out reviews that could inhibit product approvals. Agency staff, on the other hand, have repeatedly assured industry that such inspections are intended only to confirm the existence of a design control program--not to determine the adequacy of its performance as represented by a company's products.
"FDA has committed itself to the policy that design control inspections should not challenge a product's performance, only the design control system itself," says Jim Sandberg, director of product assurance and regulatory affairs at Protocol Systems, Inc. (Beaverton, OR). "Designing an adequate inspectional system will require a good cross section of people from industry. Design control doesn't apply to complex devices and systems the same way it does to in vitro diagnostics. The principles are the same, but the issues are different."
Trautman's announcement was delivered as part of her presentation to the 39th annual educational conference of the Food and Drug Law Institute (Washington, DC) last December. While confirming that FDA still expects the revised GMP regulation to be published this spring, Trautman also hinted broadly that there may be some delay in making it effective--a concession to earlier recommendations by a number of industry associations. "Industry will have adequate time to come into compliance with the regulation as a whole, including its design control requirements," she noted.
Trautman indicated that FDA expects the design control inspection committee to meet for the first time this September and to complete its work by spring 1997. She also said that the agency is working to develop guidances and other materials for use by both agency and industry personnel.
"I suspect that a lot of FDA staff have not inspected or worked with complex design control systems before," says Sandberg. "Ensuring consistency across the country will be a challenge for the agency."
Key training materials identified by Trautman include guidance documents on design control (draft due in February), human factors (summer 1996), and design and process validation (due sometime in 1996). The agency is also working on a series of training videotapes, which it expects to make available this summer.--Steven Halasey