Facility investigators with the US Food and Drug Administration have spent years training to inspect a MedTech manufacturer under the agency’s upcoming Quality Management System Regulation (QMSR), an FDA official says. But this summer, investigators will face arguably their biggest challenge yet as they undergo live training.
Anne Reid, director of the agency’s Office of Medical Device and Radiological Health Inspectorate (OMDRHI), said on April 23 at MedCon 2025 that investigators must first complete a block of 17 training modules – some only 20 minutes long, while others are hours in length – before they can participate in the pilot-tested live training.
“We’ve made some adjustments to the pilot, and now this summer, we’re going to roll [the live investigator training] out to all the staff at OMDRHI, a few at OBI, some folks in CDRH, and others that might need to learn about medical device inspection. So that’s been a lot of effort. We’re still in the middle of it,” Reid said. “That’s what we’re currently focusing on is the training of personnel.”
OBI is the FDA’s Office of Biologics Inspectorate and CDRH is the agency’s Center for Devices and Radiological Health.
The FDA published its final QMSR rule, which harmonizes the current Quality System Regulation (QSR) with international quality systems standard ISO 13485:2016, in 2024; the QMSR goes into force on Feb. 2, 2026. The QSR has been the bedrock rule for making safe and effective devices bound for the US market since the mid-1990s.
In a separate April 23 MedCon session, OMDRHI Senior Advisor Karen Masley-Joseph pointed out that the FDA’s decades-old Quality System Inspection Technique, or QSIT, will be retired – but not replaced by a “QSIT No. 2.” (Related Story: “FDA to MedTech Companies Waiting to Comply With New QMSR Rule: ‘Don’t Do That’” – QualityHub, April 23, 2025.)
That means a new inspection model had to be devised – which Reid explained has been taking place over the past few years. “A lot of work has gone into developing a new model for inspections – developing the way we talk about the work and looking at how we’ve changed and how things are going to change,” she said.
Reid went on, noting that prepping for the QMSR “has been a long road for OMDRHI and CDRH. CDRH took the pen when it came to the rule. And on [the OMDRHI] side, we’ve been working very hard on [the reg’s] implementation. These things don’t happen in a vacuum. It’s a lot of work. I have a large team of people that spend a lot of their days working on a new inspection model and resources for investigators and training and all the things that go into that.
“To say this is the biggest change since 1996 is not an understatement.”
FDA’s Reid: Contact DICE With Questions About QMSR
Reid further noted that the FDA has been busy revising relevant regulations, polices, procedures, and other documents in advance of the QMSR coming into force.
“Internally, we have to change all our standard operating procedures, work instructions, templates, and more to reflect the new regulation, and then [communicate all of that, both] internal and external,” she said. “I think we’ve been doing a pretty good job of communicating externally, [although there are] probably some areas where we can communicate more, and we will do so.”
Reid says the FDA’s Division of Industry and Consumer Education, or DICE, has developed a list of frequently asked questions and answers, and suggests that companies contact that division if they have any questions that they can’t find the answers to.
Rest assured, “there’s a team in the background that’s answering those – so please feel free to reach out if you have questions,” she said.
