Harmonization of International Standards on Device Quality Management Systems

The U.S. Food and Drug Administration (FDA) announced on 22 February 2022 that it would issue a proposed rule to align its current Good Manufacturing Practices (GMP), requirements for medical devices. This proposal was codified at 21 CFR Part 820, also known as the Quality System Regulation (the ISO), which is the international consensus standard ISO 13485.2016. This is the result of years-long efforts by the Agency to harmonize the U.S. regulations with those of many foreign regulators. The ISO is listed in EU legislation in the European Union. This means that any medical device that meets this standard will be presumed to comply with EU regulations on quality management systems. Harmonization should provide consistency among jurisdictions and allow companies to streamline their processes across countries.

The rule is being developed

The proposed rule was published by FDA in the Federal Register on 23 Feb 2022. FDA hosted a Device Good Manufacturing Practice Advisory Committee Meeting to discuss the proposed rule's potential impact and present the information.

FDA is the final outcome of the rule, known as the Quality Management System Regulations (QMSR), and it's the first major revision to the regulation since 1996. The proposed rule's primary purpose is to remove FDA's current requirements (with some exceptions) and to incorporate the ISO requirements by reference. FDA has determined that the ISO requirements are substantially similar to current FDA requirements. This means that they provide a similar level of assurance in a company's quality management system and ability to consistently produce devices that comply with the Federal Food, Drug and Cosmetic Act.

The Medical Device Single Audit Program, (MDSAP), which includes the FDA, Brazil's Agencia Nacional de Vigilancia Sanitaria, Health Canada, Japan, and Japan's Ministry of Health, Labour and Welfare, conducts audits that are based on country-specific requirements and ISO standards. The MHRA in the UK, as noted in an earlier blog article, is considering opening routes to the UK market for MDSAP-certified manufacturers. FDA found that there were very few FDA-specific requirements to be added to ISO. This reinforces the similarities between current requirements and ISO. It also allows FDA to accept MDSAP audits as an alternative to routine FDA surveillance inspections.

Additional provisions are included in the rule proposal

FDA wants to harmonize regulatory requirements and reduce inefficiencies. However, the rule proposal includes additional definitions, clarifications and requirements. FDA proposes to keep certain terms defined with minor modifications, which do not appear in ISO. This is necessary to align with the FDCA regulations. FDA proposes to NOT include, but instead supersede certain defined terms from the ISO. For example, FDA intends to retain its current definition of "manufacturer" as it considers it more complete than the ISO definition. To clarify how the ISO concepts relate to FDA's framework, FDA will also include these clarifications:

1. Clarify that the FDA-defined term "organisation" includes the meaning of "manufacturer".
2. The ISO phrase "safety, performance" should be interpreted as meaning the same thing as Section 520(f), FDCA.
3. Clarify that the ISO term "validation" refers only to FDA-defined "process validation".

FDA proposes supplementary provisions that detail additional requirements for record control, device labelling, and packaging control. FDA believes that these requirements are required to implement a quality control system that conforms to applicable FDA requirements. They are not part of the ISO. FDA proposes the following:

1. Including signature and date requirements for certain records
2. Specific requirements are required to ensure certain records of complaints or servicing activities include the information required by 21 C.F.R. Part 803
3. Documentation of Unique Device Identification is required for every medical device or batch according to 21 C.F.R. Part 830.
4. The current 21 C.F.R. clarification should be retained. SS 820.180 on confidentiality of records FDA receives.

FDA proposes to retain certain requirements from current requirements in order to strengthen control over labelling and packaging operations. FDA proposes to retain requirements that relate to labelling and packaging accuracy before release or storage, documenting the release of labelling for usage, and ensuring that labelling operations are established and maintained to prevent mistakes.

Next steps

FDA proposes that any final rule made based on the proposed rule become effective one year after it is published in the Federal Register. This allows manufacturers enough time to make any changes necessary to comply with ISO requirements. FDA welcomes comments on the proposal. FDA stated that it plans to replace its Quality System Inspection Technique with an inspection approach compatible with the finalised QMSR. FDA will also be involved in the implementation of the QMSR, including updating information technology systems and training.

Sophiya Williams is one of the best regulatory consultants providing services for 10+ years.