The QS regulation embraces the same 'umbrella'' approach to the CGMP regulation that was the underpinning of the original CGMP regulation. Thus, the preamble contains valuable insight into the meaning and intent of the QS regulation. The preamble describes the public comments received during the development of the QS regulation and describes the FDA Commissioner's resolution of the comments. For additional information on the history and international harmonization of the revised regulation, with international standards and the Global Harmonization Task Force (GHTF), see the preamble (pages 52602 - 52654) to the Quality System regulation (61 FR 52602). Also, the agency believed that it would be beneficial to the public and the medical device industry for the CGMP regulation to be consistent, to the extent possible, with the requirements for quality systems contained in applicable international standards, primarily, the International Organization for Standards (ISO) 9001:1994 'Quality Systems-Model for Quality Assurance in Design, Development, Production, Installation, and Servicing,” and at the time the ISO committee draft (CD) revision of ISO/CD 13485 'Quality Systems-Medical Devices-Supplementary Requirements to ISO 9001.” After an extensive effort, the part 820 revision was published on Octo(61 FR 52602) and went into effect June 1, 1997. In 1990, FDA undertook the start of the revision of the CGMP regulation to add the design controls authorized by the Safe Medical Devices Act. This regulation became effective on December 18, 1978, and was codified under part 820. Under section 520(f) of the act, FDA issued a final rule in the Federal Register of J(43 FR 31 508), prescribing CGMP requirements for medical devices. CGMP requirements for devices in part 820 (21 CFR part 820) were first authorized by section 520(f) of the Federal Food, Drug, and Cosmetic Act (the act). The quality systems for FDA-regulated products (food, drugs, biologics, and devices) are known as current good manufacturing practices (CGMP’s). Manufacturers must establish and follow quality systems to help ensure that their products consistently meet applicable requirements and specifications.

Fda iso 13485