The QS regulation is in Part 820 of Title 21 of the Code of Federal Regulations (CFR). This regulation covers quality management and organization, device design, buildings, equipment, purchase and handling of components, production and process controls, packaging and labeling control, device evaluation, distribution, installation, complaint handling, servicing, and records. The preamble describes the public comments received during the development of the QS regulation and describes the FDA Commissioner's resolution of the comments. Thus, the preamble contains valuable insight into the meaning and intent of the QS regulation.

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