Aligning ISO 13485 and FDA QSR 21 CFR 820 for Medical Devices

Introduction:

The US Food and Drug Administration (FDA) has proposed a new framework that would harmonize its medical device quality management system (QMS) regulation, 21 CFR Part 820, to the ISO 13485 QMS standard. This draft would align the Quality System Regulation (QSR) with requirements for medical device manufacturers and with quality system requirements in markets internationally. It would also simplify medical device regulation across US markets.

Background:

The FDA initially discussed harmonizing the QSR with ISO 13485 in 2018. On February 23, 2022, the FDA introduced a proposed rule for the forthcoming Quality Management System Regulation (QMSR). This QMSR provides modifications to Part 820 with ISO 13485:2016. Finalization of the QSMR has not occurred as of June 2023 but is anticipated by December 2023 based on a timeline in their published agenda.

ISO 13485’s most recent revision occurred in 2016, while the QSR has been static since its release in 1996. The FDA has reviewed the 2016 ISO revision and determined this revision of the standard closely aligns with and is similar to the requirements of 21 CFR Part 820. Harmonizing FDA regulations with ISO 13485 is expected to reduce the regulatory burden for device makers by eliminating redundancies involved in complying with both the ISO and QSR standards.

One key observation is that the FDA will retain its inspectional authority; FDA inspections will not result in the issuance of certificates of conformance to ISO 13485, and manufacturers who have ISO 13485 certificates are not exempt from FDA inspections.

Proposed Changes:

The first obvious change is the title of the FDA document. The Quality System Requirements (QSR) will become the Quality Management System Regulation (QMSR), and the new document will reference subclauses from ISO 13485:2016. Also included will be new definitions, clarifications, and requirements. These changes will not affect the intent of the requirements. Where items in ISO 13485:2016 are not consistent with the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA will maintain existing terms. Examples include “device” and “labeling”, which will supersede the definitions for “medical device” and “labeling” in ISO 13485.


The proposed rule also introduces several new sections in Part 820, including:

  • Section 820.7   – Incorporation by reference
  • Section 820.10 – Requirements for a quality management system
  • Section 820.15 – Clarification of concepts
  • Section 820.35 – Control of records
  • Section 820.45 – Device labeling and packaging controls

Risk Management and Risk Based Decision Making is a key difference between ISO 13485:2016 and the QSR. The current QSR addresses risk management activities in the context of the risk analysis associated with design validation. The FDA is expecting manufacturers to “integrate risk management activities throughout their QMS and across the total product lifecycle.” ISO 14971:2019 Medical devices — Application of risk management to medical devices is a reference in ISO 13485:2016 and is an excellent resource of a risk management process.

A detailed summary of changes can be found at the links below:

Implications:

It is important for medical device companies to understand the proposed changes in the QMSR and to monitor and review when the final revision is published since changes may still take place.

Items to consider as the FDA QSR is harmonized with ISO 13485:2016:

  • Top Management is expected to establish a culture of quality which the FDA expects is a key component to ensure safe and effective medical devices.
  • There is an emphasis on risk management and risk based decision making throughout the system as well as the device life cycle.
  • The FDA will clarify beyond ISO 13485:2016 the application to all Class device types and extend traceability requirements for devices that support and sustain life.
  • The FDA will replace the current Quality System Inspection Technique (QSIT) with an approach that aligns with the new requirements of the QMSR.
  • The QMSR would require manufacturers to develop a QMS that complies with ISO 13485, as modified by the proposed Part 820. Harmonization with ISO 13485 does not automatically lead to the issuance of an ISO 13485 certification of conformance after an inspection, if a manufacturer already holds an ISO 13485 certificate.
  • The final rule will take effect one year after it is finalized.

Final Comments:

The FDA believes that harmonizing the two standards will both contribute to regulatory simplicity and global harmonization and reduce burdens on regulated industries as well as medical device companies meeting the requirements of both the QSR and ISO 13485. It is important that medical device companies stay informed since modification can still take place. Being informed can help companies plan transition actions when the final version of the QMSR is released.

Authors:

Angelo Scangas – CEO and Chief Customer Officer

Bob Deysher – Senior Consultant, Quality Systems/Risk Management/Auditing

References:

https://www.compliancequest.com/blog/merger-iso-13485-and-fda-qsr-21-cfr-820/

https://www.skadden.com/insights/publications/2022/03/fda-proposes-amendments

https://www.emergobyul.com/news/us-fda-formally-proposes-aligning-quality-system-regulations-iso-13485

https://www.greenlight.guru/blog/21-cfr-part-820

https://d2evkimvhatqav.cloudfront.net/documents/nsf_md_21_cfr_820_iso_13485_2016.pdf

https://www.fda.gov/media/160124/download

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820

https://www.thefdagroup.com/blog/qmsr-quality-management-system-regulation

https://www.medasiagroup.com/blogs/medinsight/decoding-qmsr

ISO 13485:2016   Medical devices — Quality management systems —Requirements for regulatory purposes

ISO 14971:2019   Medical devices — Application of risk management to medical devices ISO 24971:2020   Medical devices – Guidance on the application of ISO 14971

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