TITLE 21 PART 820 QUALITY SYSTEM REGULATION

• Date: February 15, 2010
• Source: www.fda.gov

Aaccording to current Good Manufacturing Practice (GMP), Part 820 of the QS regulation states that medical device manufacturers have the responsibility to use good judgment when developing their quality system and apply those sections of the FDA Quality System (QS) Regulation that are applicable to their specific products and operations.