COLUMBUS, OHIO – A US Food and Drug Administration (FDA) official says the agency’s overhaul of medical device facility inspections builds on decades of experience with its now-retired Quality System Inspection Technique (QSIT), while placing a stronger emphasis on consistency and training.
Karen Masley-Joseph, Senior Advisor in the FDA’s Office of Medical Devices and Radiological Health Inspectorate (OMDRHI), within the Office of Inspections and Investigations (OII), said the agency has expanded and unified how investigators are prepared for inspections under the new Quality Management System Regulation (QMSR).
QSIT – developed in the late 1990s by an FDA team led by former agency official and current QualityHub President Tim Wells – previously served as the backbone of device inspections. The inspection approach was mothballed on Feb. 2 when the QMSR came into force. (Related Story: “R.I.P. QSIT (1999-2026): A Requiem for FDA’s Inspection Technique,” QualityHub, Jan. 27, 2026.)
Reflecting on QSIT during an April 23 session at MedCon 2026, Masley-Joseph said there’s “more cohesive training [happening] on the inspection process this time than I ever saw in QSIT.” She added that the agency has worked to prepare investigators not just on technical requirements, but on how to conduct inspections in practice.
“We have extensive training for them on … the QMSR requirements and on the inspection process,” Masley-Joseph said. (Related Story: “3 Must-Know Things From FDA’s Town Hall on Medical Device Inspections,” QualityHub, April 1, 2026.)
“This effort is as big a shift for us as it is for industry.” – Keisha Thomas
Her comments followed a stakeholder question about the FDA’s October 2025 shift to a “Simple Reform” model, in which investigators cover a broader range of products. The change reverses a 2017 move toward specialization, where investigators focused on specific product types.
Masley-Joseph declined to “comment on any future reorg,” pointing out that no such shift has been finalized. “There could be all the best-laid plans, and there’s a million hoops that have to be jumped through,” she said. “I haven’t seen it happen yet.”
Instead, she highlighted the extensive preparation that went into implementing the updated MedTech inspection framework under the agency’s revised Compliance Program Manual 7382.850. (Related Story: “Takeaways From FDA’s Retooled Compliance Manual for MedTech Inspections,” QualityHub, March 27, 2026.)
Masley-Joseph said investigators have undergone comprehensive instruction through a mix of virtual and interactive formats, with participation extending beyond device specialists.
Training efforts included the Center for Devices and Radiological Health (CDRH), the Center for Biologics Evaluation and Research (CBER), and the Center for Drug Evaluation and Research (CDER). “It was not just the medical device inspectorate that was trained,” Masley-Joseph said. “We’ve trained very well – not only within the device inspectorate, but across other groups involved with devices as well.”
She emphasized that investigator training isn’t static and continues to evolve as more QMSR-related inspections are performed. “Now, that’s not to say that there won’t be any bumps. We’re continuing to hear investigators’ questions … and we’re clarifying as we go,” she said, stressing a goal of “continuous improvement.”
Keisha Thomas, Associate Director for Compliance and Quality in CDRH’s Office of Product Evaluation and Quality (OPEQ), added during the MedCon session that inspectorate training began well before final QMSR rulemaking. She explained that early training efforts covered areas such as risk management and international standards, including International Organization for Standardization (ISO) requirements, and were designed to build capability before implementation.
“There have been all those types of trainings that have been going on … in a steady continuum since 2020 in preparation,” Thomas said, noting that the scale of the QMSR transition has been significant for both the FDA and device makers.
“We didn’t wait until we had a rule” before beginning investigator training, she said. “We’ve been doing it all along. …This effort is as big a shift for us as it is for industry.”
Looking ahead, Thomas said the agency’s focus is on maintaining standards while supporting investigators through the transition. “Whatever commodity work that [investigators are] asked to do, they will have full foundational in that commodity, and they will be required to meet all the standards for that commodity training,” she said.
