FDA Makes Qualitythe Rule

Medical Device & Diagnostic Industry Magazine | MDDI Article Index

An MD&DI February 1997
Feature Article

QUALITY

Part 2: For better or worse, the flexibility of FDA's new quality system regulation leaves industry with a lot of room to maneuver.

In the first installment of this article (MD&DI, January 1997, pp. 114-128), GMP expert W. Fred Hooten outlined some of the major changes that have made FDA's former GMP regulation into a world-class quality system regulation. The new regulation includes not only new requirements for quality management, but also new requirements for design controls--the most important change to be incorporated into the regulation. In this installment, Hooten picks up the discussion with the new regulation's requirements for document controls.--ed.

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