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Quality System FDA Regulation for Medical Devices

Jun 03 2022

Manufacturers must establish and follow quality systems to help ensure that their products consistently meet applicable requirements and specifications.

While the current QS regulation provides sufficient and effective requirements for the establishment and maintenance of a quality management system, regulatory expectations for a quality management system have evolved since the regulation was implemented over 20 years ago. The FDA seeks to harmonize its requirements for a Quality Management System (QMS) with internationally recognized regulatory requirements for Quality Management System (QMS) for devices, ISO 13485, which is used by many other regulatory authorities.

The most recent FDA's action, would harmonize quality management system requirements for FDA-regulated devices with requirements used by many other regulatory authorities around the world and provide timelier introduction of safe, effective, high-quality devices for patients.


Manufacturers 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.

Flexibility of the QS Regulation

The regulation must apply to so many different types of devices, the regulation does not prescribe in detail how a manufacturer must produce a specific device. Rather, the regulation provides the framework that all manufacturers must follow by requiring that manufacturers develop and follow procedures and fill in the details that are appropriate to a given device according to the current state-of-the-art manufacturing for that specific device.

Manufacturers should use good judgment when developing their quality system and apply those sections of the QS regulation that are applicable to their specific products and operations, 21 CFR 820.5 of the QS regulation. Operating within this flexibility, it is the responsibility of each manufacturer to establish requirements for each type or family of devices that will result in devices that are safe and effective, and to establish methods and procedures to design, produce, distribute, etc. devices that meet the quality system requirements.

FDA has identified in the QS regulation the essential elements that a quality system shall embody, without prescribing specific ways to establish these elements. Because the QS regulation covers a broad spectrum of devices, production processes, etc., it allows some leeway in the details of quality system elements. It is left to manufacturers to determine the necessity for, or extent of, some quality elements and to develop and implement specific procedures tailored to their particular processes and devices.

Applicability of the QS Regulation

The QS regulation applies to finished device manufacturers who intend to commercially distribute medical devices. A finished device is defined in 21 CFR 820.3(l) as any device or accessory to any device that is suitable for use or capable of functioning, whether or not it is packaged, labeled, or sterilized.

Certain components such as blood tubing and diagnostic x-ray components are considered by FDA to be finished devices because they are accessories to finished devices. A manufacturer of accessories is subject to the QS regulation.

GMP Exemptions

FDA has determined that certain types of medical devices are exempt from GMP requirements. These devices are exempted by FDA classification regulations published in the Federal Register and codified in 21 CFR 862 to 892. Exemption from the GMP requirements does not exempt manufacturers of finished devices from keeping complaint files (21 CFR 820.198) or from general requirements concerning records (21 CFR 820.180).

Medical devices manufactured under an investigational device exemption (IDE) are not exempt from design control requirements under 21 CFR 820.30 of the QS regulation.

Device labeling and packaging controls

The manufacturer must ensure labeling and packaging has been examined for accuracy prior to release or storage, where applicable, to include the following:

  • The correct unique device identifier (UDI) or universal product code (UPC), or any other device identification(s);

  • Expiration date;

  • Storage instructions;

  • Handling instructions; and

  • Any additional processing instructions.

The release of the labeling for use must be documented in accordance with Clause 4.2.5 of ISO 13485.

The manufacturer must ensure labeling and packaging operations have been established and maintained to prevent errors, including, but not limited to, inspection of the labeling and packaging immediately before use to assure that all devices have correct labeling and packaging, as specified in the medical device file. Results of such labeling inspection must be documented in accordance with Clause 4.2.5 of ISO 13485.

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