The FDA Poses ‘Seven Questions’ to Begin Clarifying Details of the QSR Harmonization with ISO 13485

Last week we reported the breaking news that the FDA, after years of attempts and delays, had finally released the proposed rule to harmonize the current Quality System Regulation (QSR) outlined in 21 CFR 820 with the international standard for medical device quality management system requirements, ISO 13485:2016 to generate a new resulting regulation called the Quality Management System Regulation, or QMSR.

“For over two decades, the medical device cGMP requirements for the United States have been the QS regulation; and fundamentally unchanged. This proposed change will require both the agency, and industry to prepare for a transition to meet the newly proposed requirements,”

Taken from an FDA executive summary ahead of the Wednesday meeting with the DGMP panel.

The Device Good Manufacturing Practice Advisory Committee (DGMP) met for a full day on Wednesday along with the FDA, industry group, and other interested parties to review the overhaul of the QSR and cover a range of topics related to the harmonization effort with ISO 13485 to better understand the implications in the industry, patients, and stakeholders.  In particular, the FDA posed seven questions related to this harmonization to the DGMP panel; you can download the PDF of these questions HERE.

There are a lot of changes that the FDA and other stakeholders will have to understand and take into consideration if the harmonization is to become the final rule, especially in regard to things like risk management, which is not nearly as emphasized in the current QSR as it is in the international standard.  The FDA is looking for guidance from the panel to best understand how to integrate the risk management requirements into the new regulation as well as looking for suggestions from the panel on how to best support and train manufacturers to make the transition.

At Isometric, we’ve been reaching out to our medical device clients to make sure they are aware of the possible changes so that we can prepare for them should the proposed rule be finalized.  If you are a medical device manufacturer with a QMS that meets the QSR requirements but is not certified against ISO 13485, you may have questions as to what this might mean for you.  Don’t hesitate to reach out to us if you’re in need of guidance on how to meet the requirements of ISO 13485.  We will continue to follow this as it develops and will report regularly on the website to help medical device manufacturers to navigate the change.