FDA´s QMSR: ISO 13485:2016 and beyond

In our previous article we described FDAs effort to align the Quality System Regulation with the global Quality Management System standard ISO 13485:2016. Although this is still a proposal, it is planned to be a Final Rule in December 2023, with implementation 2024.

Even though ISO 13485:2016 will largely replace a lot of the requirements in the QSR, many other regulatory requirements still apply. The new Quality Management System Regulation (QMSR) also includes several new sections.

The main differences between ISO 13485 and the proposed QSMR are in Clause 4: Quality Management System and clause 7: Product Realization. FDA has added requirements from the current Document Controls, Labelling and Packaging Control, Records, and Servicing. The differences have been addressed in the new § 820.35 and § 820.45.

In the proposed § 820.35 FDA has added a requirement that require signature and date for records subject to Clause 4.2.5 of ISO 13485. They also added specific requirements to ensure that the information required by part 803, Medical Device Reporting, is captured in certain records of complaints and servicing activities. Unique Device Identification (UDI) is also a requirement which is not defined in 13485, only mentioned briefly in clause 7.5.8.  An interesting addition is also a clarification from the current 820.180 that reminds firms that FDA protects confidentiality of records it receives.

The additions in the proposed new section Device labelling and packaging controls, § 820.45, FDA primarily emphasises the importance of control of labelling. Manufacturers must ensure labelling and packaging has been examined for accuracy prior to release and the results of the labelling inspection must be documented. The release of the labelling for use must also be documented.

Further clarifications have been added in §820.15, for example that;

  • the term safety and performance mean the same as safety and effectiveness,
  • the organization also includes the term manufacturer,
  • validation of processes should be understood to be the same as process validation.

This is in not a complete list of the changes but highlights the main differences.

Our conclusion is that if you have an ISO 13485:2016 certificate already, and especially if your quality management system already includes requirements from the current QSR 820, the changes will be more of administrative character than a system overhaul. But for manufacturers with only ISO 13485-certificates that want to expand to the US, things may become a little bit easier. We keep our fingers crossed.

If you have any question, contact us at info@qadvis.com.