The U.S. FDA's current Good Manufacturing Practices (GoodManufacturingPractices, GMP) are set forth in the QualitySystem (QualitySystem, QS) regulations, published in the Federal Food, Drug and Cosmetic Act (Food, Drug and Cosmetic, FD&C) section 520. GMP requires any domestic or foreign manufacturer to establish a quality system for the design, manufacture, packaging, labeling, storage, installation, and servicing of finished medical devices intended for sale within the United States. The quality system regulations require the establishment of various technical specifications and control standards (controls) for devices; require devices to be designed under a quality system to meet those specifications; require devices to be manufactured under that quality system; require products to conform to those specifications; require devices to be properly installed, inspected, and serviced; require quality data to be analyzed to identify and correct quality problems; and require complaints to be filed. quality data is analyzed to identify and correct quality problems; and complaints are handled. Thus, quality system regulations can help ensure that medical devices are safe and effective for their intended use, and FDA monitors device failure data and examines the processes and records of device developers and manufacturers to determine compliance with the GMP requirements of the quality system regulations.
The quality system regulations are contained in Title 21, Part 820 of the Code of Federal Regulations (CFR). The regulations cover quality management and organization, device design, plant, equipment, parts procurement and handling, manufacturing and process controls, packaging and labeling controls, device evaluation, distribution, installation, complaint handling, maintenance, and records. The introduction describes the public comments received during the drafting process of the quality system regulations and the FDA Administrator's answers to the public comments. As such, the Introduction contains valuable insights into the meaning and significance of the quality system regulations.