Fred Cowdery

Fred Cowdery

Director, Regulatory Affairs

March 28, 2024

FDA’s Final Rule Overview of Quality System (QS) Regulation/Medical Device Current Good Manufacturing Practices (CGMP)

In 1987, the International Organization for Standardization (ISO) issued the first version of ISO 9001, a standard intended to define the basic requirements, structure, responsibilities, and procedures required to implement an effective quality management system for manufacturing organizations in general. In 1996, the International Organization for Standardization issued the first version of ISO 13485, “Quality Systems—Medical Devices—Particular Requirements for the Application of ISO 9001,” to specify, in conjunction with the application of ISO 9001, the Quality Management System (QMS) requirements for medical device manufacturers. Today, ISO 13485 is used internationally by many regulatory authorities as the foundation for defining regulatory QMS requirements for medical device manufacturers and is utilized in regulatory harmonization programs such as the Medical Device Single Audit Program (MDSAP).

FDA’s Final Rule Overview of Quality System (QS)

Over time, ISO 13485 has evolved, with the current editions (ISO 13485:2016) becoming more closely aligned with the current requirements set forth in Food and Drug Administration (FDA) 21CFR part 820 QS regulations.

FDA Quality System Regulations: Scope of Changes

The FDA recognizes the similarities between the current Quality System (QS) regulations (21CFR820) and ISO 13485:2016 and is therefore taking the opportunity to harmonize 21CFR part 820 QS by amending sections of the QS for closer alignment with ISO 13485:2016. The revised QS will be renamed the Quality Management Systems Regulations (QMSR). With a couple exceptions, the majority of changes to the QS are intended to align terminology between QS and ISO 13485 regulations.

However, there are some more significant changes as follows:

  • 21CFR830.35, Control of
    • RecordsRevised for alignment with ISO 13485:2016 clause 4.2.5, to specifically address UDI.
    • Requirements for control of records, especially around certain records that interface with other requirements in the FD&C Act such as records of complaints and servicing activities required by part 803, Medical Device Reporting and UDI in accordance with part 830, Unique Device Identification (specified in § 820.35 of the final rule).
  • 21CFR820.40, Control of Device Labeling and Packaging
    • ISO 13485 does not specifically address the inspection of labeling by the manufacturer. Therefore, the FDA is retaining the existing QS, which provide stronger controls for labeling and packaging operations requirements, and carrying them forward to the QMSR.
  • 21CFR180(c), Records – General Requirements
    • Under the current QS requirements, manufacturers are not obligated to share certain quality records such as management review records, internal quality audit reports and supplier audit reports, to FDA inspectors. This is an exception unavailable to manufacturers inspected by other regulators or audited by other entities (e.g., MDSAP auditing organizations). For global harmonization, the FDA has removed this exception in the QMSR final rule.
  • The current FDA QS regulations use terms such as Device Master Record (DMR), Design History File (DHF), and Device History Record (DHR), which do not appear in ISO 13485 and are not separately defined in the QMSR final rule. Going forward, US Medical device manufacturers should refer to these tile types as the Medical Device File (MDF), as they are currently referred to in ISO 13485.

Interested in learning more on the FDA’s final rule overview of quality system regulations/medical device current good manufacturing practices? Check out our Regulatory insights paper below that takes a deeper dive into this discussion.

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