Columbus, Ohio – Officials with the Food and Drug Administration (FDA) are warning medical device manufacturers to make sure their quality system complies with the US agency’s new Quality Management System Regulation sooner rather than later. The QMSR, which goes into force on Feb. 2, 2026, will replace the FDA’s decades-old Quality System Regulation (QSR), the bedrock rule for making safe and effective devices bound for the American market.
“What should we say to companies that would possibly wait until February 1, 2026, to prepare? The short answer is, ‘Don’t do that,’” Keisha Thomas, associate director for compliance and quality within the FDA’s Center for Devices and Radiological Health (CDRH), told QualityHub.
These companies “need to be prepared – and it’s not too late. They’ve got a little less than 10 months now [to comply]. They should get on the ball by assessing their quality system, doing a gap analysis, and understanding where they are meeting the requirements of the QMSR with the quality system that they [currently] have,” said Thomas, whose comments came at MedCon 2025 in Columbus, Ohio.
The FDA published its final QMSR rule, which harmonizes the current QSR with international quality systems standard ISO 13485:2016, in 2024.
The agency “did give two years [to comply with the QMSR]. We thought we were very generous in that regard,” Thomas explained. “We’ve consistently said that we think the requirements are very similar [between the QSR and ISO 13485]. And when I say ‘similar,’ we’re not saying that it’s an easy transition [to the QMSR], but we think the requirements are similar enough that industry can do this.”
Nevertheless, “we don’t want [MedTech manufacturers] to get caught thinking [the QSR and ISO 13485] are so similar that they have no work to do,” she added. “They will have to align terminologies; they will have to make sure other [necessary] things are [in place] – so they want to be as prepared as possible.”
Thomas urged companies with questions about the transition from the QSR to the QMSR to email the agency for more information, pointing out that the FDA’s Division of Industry and Consumer Education (DICE) would be a particularly appropriate office for confused device makers to contact.
Kiss QSIT Goodbye for FDA Facility Inspections
Meanwhile, Karen Masley-Joseph, senior advisor in the FDA’s Office of Medical Device and Radiological Health Inspectorate, explained at MedCon that the agency’s Quality System Inspection Technique, or QSIT, will be retired and not replaced by “QSIT No. 2.”
Created by QualityHub founder and ex-FDA official Tim Wells in 1999, QSIT gives manufacturers a roadmap for how a facility inspection conducted by the agency will unfold.
“QSIT is going to be retired and … the replacement process will be described in the [medical device] Compliance Program when that comes out,” Masley-Joseph said. “We will not [replace QSIT with] a standalone document, like another QSIT.”
The agency’s website explains: “FDA’s Compliance Programs provide instructions to FDA personnel for conducting activities to evaluate industry compliance with the Federal Food, Drug, and Cosmetic Act and other laws administered by FDA.”
“Compliance Programs are the place where we document our inspection processes. All the Compliance Programs have sections [that call out] inspections,” Masley-Joseph said. These sections describe “inspection strategies, and there are also appendices that have more detailed information about the inspection process. There’s a part … that also talks about implementation of the program, kind of talking about how we go about scheduling inspections,” and more.
“You’ll see that we have [Compliance Programs] for drugs and biologics and combination products and [other commodities], and typically, that is where inspection processes are documented,” she noted. By eliminating QSIT altogether, FDA is simply “aligning with the rest of our Inspectorate.”
Masley-Joseph also recommended that MedTech firms look to the Medical Device Single Audit Program (MDSAP), from the International Medical Device Regulators Forum (IMDRF), to get an even better idea of what an FDA investigator might review during a QMSR-related inspection. Under MDSAP, manufacturers can undergo one audit to satisfy the regulatory requirements of five countries: Australia, Brazil, Canada, Japan, and the US.
“The MDSAP audit plan is out there, and the FDA receives reports from that. So, if people want to look at ISO 13485 and see what is expected of different clauses under MDSAP, that’s always a good reference,” she said. “There’s information [in the audit plan] about what [MDSAP] looks at. [But the FDA is not] going to provide interpretation or details. QSIT does have a lot of extra information in it that isn’t about the inspection process. And you know, that’s not going to be in the Compliance Program [for devices] – just the inspection process itself [will be in that Compliance Program]. And again, that’s just to be consistent across the FDA.”
