A 31-year veteran of the US Food and Drug Administration says it wasn’t until he began working with MedTech manufacturers after leaving the agency that he rethought the important prep work that companies need to do to comply with the FDA’s forthcoming Quality Management System Regulation (QMSR).
While QualityHub VP Sean Boyd always knew that switching from the agency’s current Quality System Regulation (QSR) to the QMSR would involve a shift in thinking and preparation for MedTechs, he now realizes that it will be more challenging for firms than he had originally envisioned while as an FDA official.
Boyd left the FDA earlier this year after more than three decades directing various regulatory, quality, and compliance efforts. Immediately before joining QualityHub in April, he was director of the Office of Regulatory Programs in the Office of Product Evaluation and Quality (OPEQ), within the agency’s Center for Devices and Radiological Health (CDRH).
“My thinking has evolved … particularly since I left FDA,” Boyd told MedTech Leading Voice in a recent interview. “Initially, my thinking was, it was very minimal change for industry … but I think there’s still work for companies to do to understand the crosswalk and make changes to align with the QMSR.” [Editor’s Note: Click here to read more of the recent MedTech Leading Voice interview and discover other important insights from QualityHub VP Sean Boyd.]
The crosswalk Boyd refers to is the comparison of terms, requirements, and various elements of the current QSR and the new QMSR. Industry must make necessary updates to internal policies, processes, and systems – and train their staff on those changes – to successfully implement the QMSR when it takes effect in February 2026. Further, the FDA’s longstanding Quality System Inspection Technique (QSIT) will be discontinued at that time in favor of a new inspectional approach by the agency that has yet to be made public.
“One of the big questions in my mind is, what is that new inspection model going to look like?” Boyd said. “It’s going to be published in a compliance program that will be released before Feb. 2, 2026. And I think that’s what everybody’s waiting to see right now.”
[Editor’s Note: Scratching your head in confusion as your device company gears up to comply with the FDA’s new QMSR? Then contact QualityHub today and let our vast network of regulatory, quality, and compliance consultants do the heavy lifting for you.]
