Medtech companies that do not have experience marketing products outside the U.S., as well as combination product manufacturers, may find it more challenging to comply the QMSR, according to Kimberly Trautman, Medical Device Expert and Former Associate Director of International Affairs at FDA’s Center for Devices and Radiological Health (CDRH).
Trautman also expressed concern that the Agency may have lost a number of specialized Investigators within the last year, which may make adjusting to the transition more challenging.
FDA first proposed to harmonize its former Quality System Regulation (QSR) with international standards, particularly the International Organization for Standardization (ISO) 13485:2016 standard for quality management systems for medical devices, in February 2022. On 2 FEB 2026, the Agency transitioned to the QMSR and published a new Compliance Program Manual: Inspection of Medical Device Manufacturers (7382.850) to replace two previous manuals.
Trautman told Focus that manufacturers that are already complying with the QSR and ISO 13485 will not face much difficulty complying with QMSR. Similarly, she said manufacturers that are audited under the Medical Device Single Audit Program (MDSAP) under jurisdictions in the US, Canada, Australia, Brazil, and Japan, will not be greatly burdened because the base of the program is ISO 13485.
However, Trautman noted that small companies focused on marketing in the U.S. and companies making combination products may have more difficulty complying with the new regulation because they are not accustomed to meeting certain aspects of QMSR, such as increased management responsibilities, supplier controls, and risk management. “It’s not that the pharma industry doesn’t have risk management,” said Trautman. “But they have it in ICH Q9 guidance, which is not audited to.”
She also noted that some combination product companies believe QMSR does not apply to them because FDA has a separate compliance program for combination products. However, she noted that the new FDA Compliance Program’s refer manufacturers to the medical device compliance program if their product contains a medical device component. “I am surprised and saddened that some people are thinking that because they’re combination products, that this isn’t going to affect them,” said Trautman. “I think that is a very wrong misconception. They need to be aware that both the regulation absolutely applies to them, and this new Compliance Program will affect them because the combination product compliance program references this new, revised [Medical Device Compliance Program].”
Since FDA announced that it was going to transition to QMSR, industry has been asking how the Agency planned to inspect and enforce the new regulatory system. To shed more light on its thinking, FDA published its Medical Device Compliance Program Manual on 30 JAN 2026 that details how its inspectors intend to ensure manufacturers comply with QMSR. “For folks that have been evolving with the science and the program, anybody who is in MDSAP and being audited under MDSAP, the inspectional strategy, the Compliance Program, that was issued on Friday (30 JAN 2026) is not going to be anything earth-shattering at all,” said Trautman. “It’s very similar in quality concepts, but it does, for example, have risk management right there at the center.
Trautman said that over the past few years, FDA has made a big push to train staff to become ISO 13485 Specialists, ensuring they are ready for the QMSR transition. However, she noted that many of those staff have been fired or left the Agency in the past year, raising concerns about the Agency’s ability to implement the new regulation. “As FDA has lost, through a variety of different mechanisms, a fair amount of Investigators over the past year, it will be very interesting to see how the Investigators actually perform this on the ground,” she added. “I just think we’re all going to have to go back to the days of when we had Generalists all the time doing FDA inspections. Companies are going to have to be confident in how they implement their QMSR to meet the requirements and meet the intent and are going to have to be confident enough to be able to explain that to an FDA Investigator their rationales,” she added. “Like anything new, I think there’ll be a little bit of a growing-in period for the inspections.”
REFERENCE: RAPS (Regulatory Focus)/Regulatory News; 02 FEB 2026; Ferdous Al-Faruque