21 CFR 820 Quality System Regulation - Current good manufacturing practice (CGMP) requirements are set forth in this quality system regulation. The requirements in this part govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use. The requirements in this part are intended to ensure that finished devices will be safe and effective and otherwise in compliance with the Federal Food, Drug, and Cosmetic Act (the act). This part establishes basic requirements applicable to manufacturers of finished medical devices.
Guide to Inspection of Quality Systems – This document provide guidance to the FDA field staff on new inspectional process that may be used to assess a medical device manufacturer’s compliance with the Quality System Regulation and related regulations. The new inspectional process is known as the “Quality System Inspection Technique” or “QSIT”. Field investigators may conduct an efficient and effective comprehensive inspection using this guidance material which will help them focus on key elements of a firm’s quality system. (August 1999)
