FDA’s Federal Register: Medical Device Quality
System Regulation
PRICE:
$2.75
CODE: 20090
ORDER
Current good manufacturing practice (CGMP) requirements for medical devices 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. CGMP requirements for medical devices are enumerated in Part 820, Quality System Regulation, of the Code of Federal Regulations (21 CFR part 820) reproduced by STAT-A-MATRIX in this handy pocket-sized edition for ease of use.
