December 22 2022
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).
Flexibility of the QS Regulation
The QS regulation embraces the same "umbrella'' approach to the CGMP regulation that was the underpinning of the original CGMP regulation. Because 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. The responsibility for meeting these requirements and for having objective evidence of meeting these requirements may not be delegated even though the actual work may be delegated.
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.
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.
Frequently Asked Questions :
Q: Why is the FDA taking this action?
A: The FDA is focused on advancing and continually improving the quality, safety, and effectiveness of medical devices to meet patient needs. This action, if finalized, will harmonize key areas of a device manufacturer’s Quality Management System and will more closely align the United States with many other regulatory authorities around the world.
Q: What is the difference between ISO 13485 and the current 21 CFR Part 820?
A: There are a lot of similarities between the requirements of the QS regulation and the clauses of ISO 13485:2016. The substance of the ISO 13485 requirements and the activities and actions required for compliance are substantively the same as under the current Part 820. The most noticeable difference between the QS regulation and the standard is the risk management requirements integrated throughout the aspects of the quality management system in ISO 13485. This differs from 21 CFR 820, in that the only risk-specific requirement in the QS regulation is listed in §820.30(g), as it relates to risk analysis as a part of design validation.
The ISO 13485 standard will be incorporated into the regulation, 21 CFR Part 820, if finalized. Though the proposed regulation will incorporate the requirements of ISO 13485:2016 as the foundational quality management system requirements, there are additional FDA-specific requirements created to ensure consistency and alignment between ISO 13485 and existing requirements in the FD&C Act and its implementing regulations.
Q: What is the FDA doing to prepare for harmonization of the Quality System Regulation with ISO 13485?
A: The FDA intends to engage in a variety of implementation activities including, updating information technology systems, training FDA staff responsible for assessing compliance with medical device quality management system requirements, developing an inspection technique, revising relevant regulations and other documents impacted by this rulemaking, and communicating and educating stakeholders, including affected FDA staff, on the change.
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