US FDA looks to harmonize and modernize the regulation of Quality Systems for manufacturers of medical devices

The US FDA has made a formal announcement of its intention to replace certain aspects of the existing Quality System Regulation (QSR) with specifications of the international consensus standard ISO 13485:2016. This change is currently at the proposed rule stage.

The QSR is published in the Code of Federal Regulations (CFR) and is often referred to by its publication reference of 21 CFR 820. The FDA Commissioner, Dr Scott Gottlieb, included this proposed change as one of his priorities in his post on the Spring Unified Agenda that shared FDA’s anticipated upcoming regulatory work.

In the official announcement, the FDA presents this change as an opportunity to harmonize and modernize the way that quality systems are regulated in the USA.  The intention is to reduce the cost of compliance and the burden of record keeping by harmonizing the US expectations with the international standard that has been adopted or recognized in many other jurisdictions.

This change, if finalized, is seen as making compliance more efficient for manufacturers who sell their products internationally. Although the QSR was itself based on many elements included in the first edition of ISO 13485, published in 1996, the QSR has not been updated as regulatory expectations have evolved over time.

ISO 13485:2016, Medical devices — Quality management systems — Requirements for regulatory purposes, including the corrigenda to the European Foreword and Annexes Z, is now harmonized in Europe for the active implantable devices, medical devices and in vitro diagnostic devices Directives.  ISO 13485:2016 is also used in many other countries to meet the Quality Management System (QMS) requirements in their jurisdictions. Harmonizing QMS requirements globally supports the convergence of regulatory requirements in different countries and regions.

With publication of 13485:2016, there have been evaluations conducted of how regulatory requirements are linked to the standard. There are a lot of similarities between the requirements of the QSR and the clauses of ISO 13485:2016, much more than there was with the previous edition of the standard from 2003, despite their common roots. 

FDA has always had an interest in seeking ways to harmonize requirements with ISO 13485. These have included its voluntary pilot program that allowed submission of audit reports to ISO 13485 performed by Conformity Assessment Bodies in lieu of routine inspections. This pilot was a precursor to its active participation in the Medical Device Single Audit Program (MDSAP). MDSAP has ISO 13485:2016 as one of its foundations.

There are many practical steps that need to be taken before this change is adopted. Not least of these is the administrative task of identifying and addressing the many links and cross-references between other aspects in the Code of Federal Regulations to the QSR. Additionally, the mechanism for the US regulation to remain aligned with any future revisions to ISO 13485 needs to be considered.

However, the announcement indicates that the FDA is committed to taking this important step in international harmonization in regulatory requirements for QMS.

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