For decades, there has been a divide in the medical device regulatory landscape. While the U.S. Food and Drug Administration (FDA) has considered their Quality System Regulation (QSR) to be the minimum criteria for medical device manufacturing since 1996, international standards differ. This discrepancy challenges medical device companies, as they must struggle to meet multiple standards or lose access to international markets. The FDA, recognizing the need for harmonization across device regulation, has announced intent to align with the international consensus standard of ISO 13485:2016. What are the potential consequences, and how can device companies prepare now for the switch to ISO 13485:2016?
The FDA, recognizing the need for harmonization across device regulation, has announced intent to align with the international consensus standard of ISO 13485:2016.
QSR and ISO 13485:2016
21 CFR 820 is the part of QSR that defines design, manufacturing, and more for medical devices. The FDA’s Center for Devices and Radiological Health (CDRH) estimates that the overlap between 21 CFR 820 and ISO 13485:2016 is 95%, but the remaining 5% contains several key differences. The switch to ISO 13485:2016 will mark the adoption of a for-cause approach versus risk-based, with an emphasis on risk management. Cursory review of both reveals that document control, risk management, regulatory reporting, and more will need to be reconciled once the transition occurs.
The FDA has already come out in strong support of ISO 13485:2016. For years, many U.S. companies have met this standard alongside QSR, even though it is voluntary. Adoption of ISO 13485:2016 places the FDA in the company of several major nations and facilitates easier market access. Tellingly, both Japan and Canada have already begun similar harmonization programs with their own quality regulation. Use of the Medical Device Single Audit Program (MDSAP) will also simplify manufacturer inspections. MDSAP is based upon ISO 13485:2016, and the FDA plans to leverage the program following the transition.
International medical device companies that operate under ISO 13485:2016 but not 21 CFR 820 will gain streamlined access to a new market, but for QSR-only U.S. companies, a rough transition lies ahead. Quality manuals will need to be overhauled, staff retrained, and inspections passed anew. Most will eventually be able to meet ISO 13485:2016 and resume activity, but a period of volatility during the change is likely.
Quality manuals will need to be overhauled, staff retrained, and inspections passed anew.
Many medical device manufacturers are already operating under both 21 CFR 820 and ISO 13485:2016. For these companies, the FDA switch to ISO 13485:2016 will streamline their regulatory compliance once completed. Internal quality systems and associated personnel will be able to focus on ISO 13485:2016 instead of dividing attention. Inspections will be simplified as well, with a single MDSAP audit likely to replace multiple visits.
However, a smooth MDSAP transition is far from given. Historically, FDA officials have struggled to interpret MDSAP results, and significant staff retraining will be necessary. MDSAP itself has also recently raised concerns over systematic review of ISO 13485:2016, which could potentially cause complications if no resolution is reached. The MDSAP Regulatory Authority Council (RAC) has advocated against proposed new revisions to ISO 13485:2016, which was updated just a few years ago. RAC Chair David Boudreau states, “If changes are implemented to ISO 13485:2016, the audit model for MDSAP, which was just recently revised, will have to be completely revised, training of the Auditing Organizations will need to be conducted, and transition periods will need to be implemented leading to instability in the MDSAP at a critical time”. MDSAP instability at the same time as the FDA transitions to lean on the inspection program could spell disaster for companies seeking approval.
Preparing for the Upcoming Transition
With little currently known about the upcoming harmonization, how can companies prepare in advance? Regardless of the final details, manufacturers under QSR compliance serving the U.S. medical device market should read up on ISO 13485:2016 now and recognize necessary internal changes. Personnel will need to undergo retraining, so scheduling a QA learning session or town hall could identify staff concerns and lean on existing knowledge. The FDA will be hosting informational sessions as well, which are definitely worth attending.
Regardless of the final details, manufacturers under QSR compliance serving the U.S. medical device market should read up on ISO 13485:2016 now.
A second strategy is to bring in existing ISO 13485:2016 knowledge to your organization. While the FDA switch to ISO 13485: 2016 is new, this standard has long been utilized by medical device manufacturers in the U.S., and experienced personnel already exist. Quality departments can preemptively hire and onboard staff with a deep understanding of ISO 13485:2016 to streamline the eventual transition. For companies that utilize external manufacturing capabilities, working with a contract manufacturing organization (CMO) that already operates on ISO 13485:2016 will avoid the transition period.
While the full scope of the FDA’s harmonization plan is still being revealed, there are actions that can be taken now to minimize future disruptions. With preparation, the transition should have positive outcomes for most manufacturers by streamlining compliance and opening new international market access. The FDA switch to ISO 13485:2016 means a simplified future for medical device regulation. Will your team be ready to welcome it?
For companies that utilize external manufacturing capabilities, working with a contract manufacturing organization (CMO) that already operates on ISO 13485:2016 will avoid the transition period.