May 14, 2022

Harmonization of international rules on quality management systems for medical devices – Food, drugs, healthcare, life sciences


United States: Harmonization of international rules on quality management systems for medical devices

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On February 22, 2022, the United States Food and Drug Administration (FDA or the Agency) announced that it was releasing a proposed rule to align the Agency’s current Good Manufacturing Practices (GMP) requirements ) for medical devices, codified in 21 CFR Part 820 and known as the Quality System Regulations, with the international consensus standard ISO 13485:2016 (the ISO). This reflects the Agency’s years of efforts to better align US requirements with those of many foreign regulators. For example, in the European Union, ISO is listed in EU legislation, which means that a medical device complying with this standard is presumed to comply with the EU regulatory requirements on management systems. the quality of medical devices. This harmonization should therefore bring some consistency between jurisdictions and allow companies to streamline their processes between countries.

Development of the proposed rule

The FDA formally published the proposed rule in the Federal Register on February 23, 2022. As part of the publication of this proposed rule, the FDA held a meeting of the Device Good Manufacturing Practices Advisory Committee on March 2, 2022, where industry groups AdvaMed and Medical Imaging & Technology Alliance attended and presented, to discuss the proposed rule and its potential impacts.

The FDA refers to the end result of the proposed rule as the Quality Management System Rule (QMSR), which is the first major revision of the rule since 1996. The main purpose of the proposed rule is to remove the current requirements of the FDA, subject to certain exceptions. , and incorporate the ISO requirements by reference. This course of action is based on the FDA’s determination that the ISO requirements are, when taken as a whole, substantially similar to the current requirements and, therefore, provide a similar level of assurance in the system. of a company’s quality management and its ability to consistently manufacture devices that are safe, effective, and otherwise compliant with the Federal Food, Drug, and Cosmetic Act (FDCA).

In addition, the Medical Device Single Audit Program (MDSAP), under which the FDA as well as the Therapeutic Goods Administration of Australia, the Agência Nacional de Vigilância Sanitária of Brazil, Health Canada, the Japanese Ministry of Health , Labor and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency participates, performs audits based on ISO and country-specific requirements. As noted in a previous blog, the MHRA in the UK is also considering introducing routes to the UK market for manufacturers with an MDSAP certificate. FDA concluded that very few FDA-specific requirements should be added to ISO, reinforcing the similarities between ISO and current requirements and allowing FDA to participate in MDSAP and accept certain MDSAP audits. instead of routine FDA surveillance inspections.

Additional Provisions in the Proposed Rule

Despite the FDA’s desire to harmonize regulatory requirements and avoid inefficiencies, the proposed rule includes definitions, clarifications, and additional requirements. For example, the FDA proposes to retain certain defined terms with minor modifications that do not appear in the ISO and are necessary to ensure alignment with the FDCA and its regulations. More specifically, the FDA proposes to
do not incorporate, and rather replace, certain terms defined in ISO, such as retaining its current definition of “manufacturer”, as the Agency considers it more comprehensive than the ISO definition. Additionally, the FDA intends to include the following clarifications for three concepts to explain how these ISO concepts relate to the FDA framework:

  1. clarify that the term “organization” also includes the meaning of the term “manufacturer” as defined by the FDA;

  2. the ISO term “safety and performance” shall be interpreted to mean the same as “safety and effectiveness” in section 520(f) of the FDCA; and

  3. clarify that the ISO term “process validation” refers to the FDA defined term “process validation”.

The FDA is also proposing additional provisions detailing additional requirements for registration control and device labeling and packaging control. The FDA position is that these requirements are necessary to implement a quality management system that complies with applicable FDA requirements that are not specified in ISO. In terms of registration control, the FDA offers:

  1. including signature and date requirements for certain records;

  2. mandate specific requirements to ensure that certain records of complaints and service activities capture the information required by 21 CFR Part 803;

  3. require documentation of unique device identification for each medical device or lot in accordance with 21 CFR Part 830; and

  4. retaining the clarification of current 21 CFR § 820.180 regarding the confidentiality of records received by the FDA.

The FDA is also proposing to retain certain requirements from the current requirements to strengthen controls over labeling and packaging operations. Specifically, the FDA proposes to retain requirements for reviewing labeling and packaging for accuracy prior to release or storage, documenting release of labeling for use, and ensuring that labeling and packaging operations have been established and maintained to avoid errors.

Next steps

The FDA is proposing that any final rule based on the proposed rule be effective one year after its publication date in the Federal Register, to allow sufficient time for manufacturers to make any necessary changes to comply with ISO requirements. However, the FDA welcomes comments on this proposal. The FDA also indicated that it intends to replace its quality system inspection technique with an inspection approach consistent with the requirements of the finalized QMSR. Additionally, FDA intends to engage in implementation activities, such as updating information technology systems, training, and reviewing relevant regulations and other impacted documents. by QMSR if finalized.

The content of this article is intended to provide a general guide on the subject. Specialist advice should be sought regarding your particular situation.

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