QSR will be retired in favor of QSMR
In February 2024, the FDA issued final guidance for medical device firms about transitioning from the current Quality System Regulation (QSR) to Quality Management System Regulation (QMSR) — which was created to align more closely with the International Standard for Medical Devices, ISO 13485.
QSR hasn’t been updated significantly since 1996, and the FDA realized that a larger overhaul of standards was needed, and took the opportunity to align with what is considered industry standard around the world.
However, just because a company is ISO 13485 certified does not mean it is automatically in compliance with QMSR — the FDA has kept some elements of the QSR where it didn’t feel ISO 13485 covered thoroughly. PTL Solutions has done the hard work for you and here are the key takeaways from the new rules:
What’s NOT Changing?
The FDA is not expanding the scope of QMSR — it only applies to manufacturers of finished devices — not components, parts of devices, or 3rd party refurbishers. However, the FDA reserved the right to expand the scope in the future, pointing out that it has the legal authority to do so per the FDCA.
What is Changing?
Key Terms: The FDA is sun setting terms like “design history file”, and now using the ISO terms which are slightly different, but cover the same material. This will simplify record-keeping for multinational device firms and align US terminology with international standards.
More Internal Records Open for Audit: This includes supplier audits, internal quality audits, and management reviews, same as required by ISO 13485. The FDA has not provided guidance as to how or when these internal documents may be reviewed going forward, but just stated that they plan to do so. In practice, FDA does not usually review internal quality audits during routine inspections, but we don’t know if that will continue to be the case under QMSR.
Inspections (maybe): FDA has said that they will be overhauling their inspection protocol, QSIT, which will be replaced with a new system aligned with QMSR; however, FDA has not made the new inspection system public, except to say they will not be issuing QMSR compliance certificates, nor will companies with an ISO 13485 certificate be exempt from inspections.
What’s in QMSR but not ISO 13485?
Labelling Controls: The FDA viewed ISO 13485’s requirements for complaint records, as well as device labelling and packaging controls as insufficient, and therefore has kept some requirements of QSR in these areas.
But what happens for the next two years?
Despite assurances from the FDA that the QMSR’s alignment with ISO 13485 will save device makers money overall ($439 million to $533 million over the next ten years) and simplify regulatory compliance, that may not be evenly felt across the industry.
Smaller device makers who have only conducted business in the US under QSR and are not ISO 13485 compliant are likely to have the heaviest administrative burden in complying with the new QMSR.
And for new devices, how they will comply with both sets of regulations almost simultaneously is unclear. As a thought exercise, it’s not hard to imagine a company requesting device clearance before February 2026 in compliance with QMSR, but who would then not be in compliance with the current QSR standards. The FDA has made it clear that device makers must be in compliance with QSR until the deadline, and no exceptions or clarifications have been made for the two-year transitional period.
Start Planning for QMSR Today
Not sure how the new regulations will impact your business? Let PTL create a regulatory roadmap and implementation plan for your device and ensure compliance with changing and opaque regulations in the US, Canada, and worldwide.
Our team is highly experienced, with over decades of experience guiding medical device manufacturers through the FDA regulatory process, and 80 products successfully brought to market.
The best way to get started is to book a free consultation with one of our experts. PTL will customize a path to market for your device that considers safety, speed, and budget.
Comentarios