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Proposed Rule: Quality System Regulation Amendments FAQs

Mar 21 2022

On February 23, 2022, the FDA issued a proposed rule to amend the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) Regulation to align more closely with the international consensus standard for Quality Management Systems for medical devices used by many other regulatory authorities around the world.

The FDA proposes to do so primarily by incorporating by reference the 2016 edition of the international standard specific for medical device quality management systems set by the International Organization for Standardization (ISO), ISO 13485. Through this rulemaking, the FDA is also proposing additional requirements that help connect and align ISO 13485 with existing requirements in the Federal Food, Drug, and Cosmetic Act and its implementing regulations, and make conforming edits to 21 CFR Part 4 to clarify the device CGMP requirements for combination products.

This action, if finalized, will continue the FDA’s efforts to align its regulatory framework with that used by other regulatory authorities to promote consistency in the regulation of devices and provide timelier introduction of safe, effective, high-quality devices for patients.

On March 2, 2022, the FDA will hold a public advisory committee meeting of the Device Good Manufacturing Practice Advisory Committee. The committee meeting will provide information about the proposed rule and offer an opportunity to discuss the requirements and potential impacts of this proposed amendment to the agency’s regulations.

This section provides answers to frequently asked questions related to the proposed rule. These questions and answers provide clarity and do not introduce any new policies or modify any existing policies.

Why is the FDA taking this action?

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.

The difference between ISO 13485 and the current 21 CFR Part 820

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.

What is the FDA doing to prepare for harmonization of the Quality System Regulation with ISO 13485?

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.

If finalized, will there be a new inspection technique?

The current Quality System Inspection Technique will be reviewed and, as applicable, revised to incorporate the requirements of the rule, if finalized.

What happens if FDA incorporates ISO 13485:2016 and the standard is revised?

If the standard is revised after FDA incorporates it as the foundation for its quality management requirements, the Agency will review the changes, assess its impact on the regulatory requirements, and make any changes needed in accordance with the Administrative Procedures Act.

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