Impact of ISO 13485 harmonization in USFDA product approval

The USFDA have proposed a rule to harmonize 21 CFR 820 to ISO 13485 QMS standard. The alignment of FDA Quality System Regulation (QSR) with ISO 13485 was first proposed in 2018, which would bring United States Quality Management System (QMS) for medical device manufacturers closer in line with quality system requirements in markets such as the European Union, Japan and Australia, potentially streamlining medical device registration and compliance processes across the U.S. and other markets.

FDA has identified the following areas 21 CFR Part 820 and ISO 13485:2016 differ to warrant additional requirements for US medical device market registrants: 

a) QMS document controls

b) Labeling and packaging control

c) Records and record keeping

d) Servicing

Although FDA considers adaptation of ISO 13485 as less of a major QMS compliance effort for medical device manufacturers, the agency notes that ISO 13485 predominantly cites risk based decision making than QSR. 

The resulting regulation would be considered as Quality Management System Regulation (QMSR). According to FDA’s analysis, the regulation as written would result in a cost savings of $439-533 million over 10 years for medical device establishments that comply with both standards. FDA is also proposing to give device makers one year from the publication of the final rule to adapt to the new regulatory requirements.

FDA 21 CFR Part 820 is the quality system regulations followed by U.S. since 1996.  The QSRs define minimum criteria for a medical device company regarding design, manufacturing, packaging, labelling, storage, installation, and servicing of medical devices sold and distributed in the U.S.

ISO 13485:2016 is a voluntary standard that defines quality system requirements which majority of the world recognizes for developing and maintaining the system that are specific to the medical device market.

In a nutshell, not much differs between the two. Both systems contain essentially the same requirements, especially since ISO 13485 was revised in 2016. ISO 13485:2016 is not a regulation or law, however, while FDA 21 CFR Part 820 is mandatory for medical device distribution in the U.S.

WHY NOW?

ISO 13485:2016 has gained significant recognition globally outside the U.S. and with the most recent version of this standard, ISO 13485 and 21 CFR Part 820 are very much in sync with one another. FDA shifting to full adoption of ISO 13485 would further solidify global regulatory harmonization efforts. Plus, the Medical Device Single Audit Program (MDSAP) rolled out within recent years has also been gaining significant momentum. One of the premises of MDSAP is to harmonize regulations and minimize audit and inspection burden for medical device companies. In fact, Health Canada is requiring ISO 13485 certification and MDSAP for medical devices entering the Canadian market starting January 1, 2019. FDA shared that it plans to also eventually use MDSAP as the means to fully adopt ISO 13485.

IMPLICATIONS FOR RISK MANAGEMENT

Another QMS topic of interest is risk management. FDA Part 820 barely mentions risk management while ISO 13485 puts a major emphasis on risk-based QMS and cites another standard, ISO 14971 for managing medical device product risk management many times. 

IMPLICATIONS FOR THE INDUSTRY

What impact will this transition from QSRs to ISO 13485 have on medical device companies? It’s expected that the impact on the currently running industry in the U.S. will be minimal, but not without some challenges. Minimal because of how in sync ISO 13485:2016 is with respect to FDA 21 CFR Part 820. Said another way, if a company has a quality management system that meets the requirements of 820 should also align with ISO 13485 requirements (key word: should). Challenging because achieving ISO certification is a separate process that requires an audit by a third party auditing organization.

What about companies who are already ISO 13485:2016 certified? These medical device companies certified to ISO 13485:2016 would likely receive significant benefits from easier US market access without having to implement FDA QSR processes.