Quality Systems

Quality system regulations from the FDA include requirements related to the methods used in and the facilities and controls used for designing, purchasing, manufacturing, packaging, labeling, storing, installing, and servicing of medical devices. Manufacturing facilities undergo FDA inspections to assure compliance with the quality system requirements.

According to FDA guidance: “Manufacturers of medical devices must establish and follow quality systems to help ensure that their products consistently meet applicable requirements and specifications. The quality systems for FDA-regulated products (food, drugs, biologics, and devices) are known as current good manufacturing practices (CGMP’s). 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). Under section 520(f) of the act, FDA issued a final rule in the Federal Register of July 21, 1978 (43 FR 31 508), prescribing CGMP requirements for medical devices. This regulation became effective on December 18, 1978, and was codified under part 820 [of the Code of Federal Regulations].”[1]

The FDA has made quality system regulations available—21 CFR 820 and Medical Device Quality System Regulation and Preamble—as well as a guidance document for quality system regulations titled Quality System Information for Certain Premarket Application Reviews – Guidance for Industry and FDA Staff.

Design controls are another factor to be considered with respect to FDA medical device regulation. Design controls are intended “to ensure that good quality assurance practices are used for the design of medical devices and that they are consistent with quality system requirements worldwide.”[2] The design controls discussed by the FDA in its guiding documents include:

  • Design and Development Planning
  • Design Input
  • Design Output
  • Design Review
  • Design Verification
  • Design Validation
  • Design Transfer
  • Design Changes
  • Design History File[2]

Human Factors is another area that falls under FDA medical device quality system regulation. According to the FDA, “for medical devices, the most important goal of the human factors/usability engineering process is to minimize use-related hazards and risks and then confirm that these efforts were successful and users can use the device safely and effectively.”[3]

Updated by Kristin Stiner, November 2020