Harmonizing Device CGMP Requirements with International Standards
In 2018, the US agreed to harmonize its domestic good manufacturing practices with agreed-to international standards in accordance with the Medical Device Single Audit Program (MDSAP). On Feb. 23, the Food and Drug Administration (FDA) made its contribution to that effort by publishing a proposed harmonization rule for medical device quality management systems (QMS) standards. The Proposed Rule The newly proposed rule on quality system regulation would revise the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) Regulation (21 CFR part 820) to align more closely with international QMS regulatory rules. The proposal, which would be the first major update to CGMP since 1996, would withdraw part 820 and replace it with International Organization for Standardization (ISO) 13485, which the agency says is “substantially similar” to the current US regulations. However, there would also be a few tweaks. The proposed rule would retain current part 820 requirements for device labeling and packaging operations, issues that ISO 13485 doesn’t address, given that many device recalls are related to labeling and packaging. The FDA also plans to include signature and date requirements for records, and ensure that companies meet reporting requirements for complaints and service activities. Nor would […]
The Proposed Rule
The newly proposed rule on quality system regulation would revise the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) Regulation (21 CFR part 820) to align more closely with international QMS regulatory rules. The proposal, which would be the first major update to CGMP since 1996, would withdraw part 820 and replace it with International Organization for Standardization (ISO) 13485, which the agency says is “substantially similar” to the current US regulations. However, there would also be a few tweaks. The proposed rule would retain current part 820 requirements for device labeling and packaging operations, issues that ISO 13485 doesn’t address, given that many device recalls are related to labeling and packaging. The FDA also plans to include signature and date requirements for records, and ensure that companies meet reporting requirements for complaints and service activities. Nor would the proposed rule affect the FDA’s authority to carry out inspections—although the agency indicated that it would modify its current approach to ensure that inspections carried out are faithful to the international requirements.Next Steps
If the rule is finalized, it would take effect one year after it was published in the Federal Register, i.e., February 23, 2023. The FDA would also need to clarify the QMS requirements for combination products, make “conforming edits” to current regulations that refer to part 820, namely, part 4 (21 CFR part 4), update its IT systems, and revise its inspections policies. Here are the important new FDA Emergency Use Authorizations (EUAs) and clearances announced in February 2022:New FDA Emergency Use Authorizations (EUAs) & Approvals
New CE Marks & Global Certifications
Notable European CE certifications announced during the period:New CE Markings in Europe
Other international clearances announced during the period:Subscribe to view Essential
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