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FDA: Out-Of-Spec Components May Be Used In Finished Devices - But Beware

This article was originally published in The Silver Sheet

Executive Summary

DEVICE FIRMS FREQUENTLY ADJUST MANUFACTURING PROCESSES to accommodate components that are out of specification, but that isn't necessarily a problem as long as the product meets "finished device specifications and all of its labeling requirements," FDA quality system expert Jan Welch says. During an agency inspection, FDA will check to see whether a firm's manufacturing change is a one-time exception or if the company makes changes on a regular basis. "The occasional one-off situation for a component or material may be acceptable with justification," Welch says. A company will typically consider the type of component, its risk of possible failure and whether it's critical to the proper functioning of the device when deciding whether to use out-of-specification components. Experts at device manufacturers Medrad, Nonin Medical and Enzymatics tell how they handle incoming material

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