US Food and Drug Administration (FDA) officials held a Town Hall webinar today to discuss its revised Compliance Program Manual (CPM) for the Inspection of Medical Device Manufacturers, or CPM 7382.850. The event gave the MedTech industry insight into the agency’s thinking as it pertains to conducting facility inspections under its new Quality Management System Regulation (QMSR).
Carrying an implementation date of Feb. 2, 2026, the updated CPM lays bare for FDA investigators what they should look and ask for during an inspection, among other activities. The CPM effectively replaced the agency’s Quality System Inspection Technique, or QSIT, an inspectional approach used by investigators since 1999 and retired in February. (Related Story: “Takeaways From FDA’s Retooled Compliance Manual for MedTech Inspections,” QualityHub, March 27, 2026.)
Three key messages emerged from the FDA’s hourlong April 1 Town Hall:
1. The inspection process for device makers will largely stay the same, FDA officials say.
For example, for “domestic inspections, investigators will give manufacturers an FDA-482 Notice of Inspection when they arrive, and then during the inspection the investigators will typically tour the facility,” 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 at the Town Hall.
“FDA does not expect manufacturers to revise or recreate records made before February 2, 2026, to comply with QMSR requirements, but they are still fair game for us to look at if the inspection direction leads us there.” – Keisha Thomas
Investigators will also “ask to see how products and processes work,” Masley-Joseph added. “They’re going to discuss what the [company’s] site does, [as well as specific employee] roles and responsibilities. They are also going to review quality data and documents, talk to and interview staff, and observe or watch processes in action.”
She continued: “Those are some of the same activities investigators have always conducted, and now they’ll just be done in a way to assess the requirements of the QMSR using the processes outlined” in CPM 7382.850.
Masley-Joseph further noted that “while investigators previously have requested risk management documentation, under the QMSR they will emphasize reviewing risk management documents and evaluating how manufacturers have effectively implemented risk controls throughout their Quality Management System,” or QMS.
2. Investigators will look at QMS records created before Feb. 2, 2026, if evidence gathered during the inspection warrant the need for their review.
“Our investigators use critical thinking to select the appropriate elements necessary to evaluate whether manufacturers are appropriately identifying and controlling risks that could adversely impact patients and users,” said Keisha Thomas, Associate Director for Compliance and Quality in the Office of Product Evaluation and Quality (OPEQ), within the FDA’s Center for Devices and Radiological Health (CDRH).
“For example, if an inspection reveals there are design deficiencies that result in a significant device recall, it may be appropriate for investigators to assess how the manufacturer is auditing – or has audited – its design and development process,” said Thomas, who also spoke at the Town Hall.
“FDA investigators may review records that are part of manufacturer’s Quality Management System, including those … created prior to February 2, 2026,” she added. However, the agency “does not expect manufacturers to revise or recreate records made before February 2, 2026, to comply with QMSR requirements, but they are still fair game for us to look at if the inspection direction leads us there.”
3. The FDA still isn’t budging on developing a new Quality System Inspection Technique.
The agency “does not intend to release an additional document that supplements the Compliance Program that includes the inspection of medical device manufacturers for QMSR inspections,” OPEQ’s Thomas said. (Related Story: “R.I.P. QSIT (1999-2026): A Requiem for FDA’s Inspection Technique,” QualityHub, Jan. 27, 2026.)
CPM 7382.850 “provides instructions to FDA personnel who are conducting activities to evaluate industry compliance with the [Federal] Food, Drug, and Cosmetic Act and other laws, and implementing regulations,” she said. “There will be no additional document that will come out in place of – in lieu of – or in addition to [the CPM] as it relates to the inspection process for QMSR.”
