MedCon: FDA readies staff, device makers for QMSR

COLUMBUS, OH – Now that the Quality Management System Regulation (QMSR) final rule has been published, the US Food and Drug Administration (FDA) is working to implement the transition, both internally and externally.

The decision to make the transition from Quality System Regulation (QSR) was easy, Keisha Thomas, director of compliance and quality with the Office of Product Evaluation and Quality (OPEQ) at the Center for Devices and Radiological Health (CDRH) in FDA, told attendees during the 2024 MedCon conference, sponsored by the AFDO/RAPS Healthcare Products Collaborative and FDA. The task of implementing the transition, however, is “not at all easy,” she said, and involves preparing both agency staff and external stakeholders.

Thomas told attendees that the agency, and particularly CDRH, is already familiar with QMSR, which incorporated by reference the international quality management standard ISO 13485, is “aligned very, very closely with the current regulation.”

“Even though we’ve been forthcoming and talking about it as a strategic priority in the last five, seven years maybe, it's not new to the agency,” Thomas said. “CDRH has always been kind of moving in this direction.”

“Even with the new terminology, it’s just some new terminology for [the] same requirements that fundamentally keep medical devices safe, effective, and high quality for US patients and consumers, so that's what we’re here for,” Karen Masley-Joseph, senior advisor in the Office of Medical Device and Radiological Health Operations (OMDRHO) in the Office of Regulatory Affairs (ORA) at FDA, told attendees at MedCon. “That’s what the goal is. We’re not changing any of that.”

FDA is currently working on updating technology systems, training personnel, revising various regulations and policies related to the transition as well as communication efforts that include presenting the details of the QMSR at conferences and seeking feedback from industry.

As part of QMSR, most of the requirements for part 820 have been withdrawn, and the ISO 13485:2016 standard has been incorporated by reference, Masley-Joseph said. FDA will still have inspectional authority, but inspections performed by FDA will not lead to companies receiving an ISO 13485:2016 certificate of conformance, she said. Likewise, companies with an existing certificate of conformance for ISO 13485:2016 are not exempt from FDA inspections. The agency will also not require companies have a certificate of conformance for ISO 13485:2016. (RELATED: FDA issues QMSR final rule with 2-year transition period, Regulatory Focus 31 January 2024)

One common question being asked by companies is whether they automatically comply with the QMSR if they currently adhere to ISO 13485:2016.

“The short answer is no,” Thomas said. “The QMSR has additional provisions and other ... requirements. So no, if you're just there with 13485 right now, you, you do not fully comply with QMSR. You have to go that next step and comply with the entirety of the requirements.”

Effective date and enforcement

The implementation date for the QMSR is 2 February 2026. As that date approaches, Thomas said there are over 1,500 internal documents at FDA that need to be updated to comply with QMSR. All the documents associated with industry will be available soon, while the agency is working to prioritize what documents and policies will launch on the effective date.

“We do have a plan. We have a whole big implementation effort, and so there are things that we’re prioritizing,” she said. “There are absolutely some of those guidance documents that will be updated in time with the effective date because they’re just that important. There may be others that you’ll see, depending on how quickly we can get through all of them, that may have the blue box on it that says that this is being updated associated with this.”

Thomas said up to 1 February 2026, FDA will still be following the QSR for “any supplement, activities, inspections, that you have in play,” but QMSR will apply for “any and all activities that are initiated on that date and after” 2 February 2026.

“[F]or a short period of time, to close out things that went up until February 1st, we will still review that in accordance with the Quality System Regulation requirements and assess accordingly,” Thomas explained. “We’re not going to have two systems at any time in operation, but there will be some lagging review assignments, activities, submissions that may come in during that time that you have to close out according to the original requirements that we have today.”

In helping industry prepare for QMSR, Thomas said the agency will be forthcoming about what its communications will look like and how FDA can offer suggestions, opportunities, and insights on the transition. “What I can assure you is we’re not going to be silent,” she said. “You will be hearing from us.”

While larger, international companies may already have experience with ISO 13485:2016, smaller US-based companies may be looking at it for the first time, and inspectors may help bridge that gap. “I think there’s a benefit in the beginning of having investigators that can interchange back and forth and still do speak the language that may not be as well versed in using the same terminology that helps those companies along, because not everyone is doing this right now,” Thomas said.

Ultimately, it will take cooperation between FDA and industry to make the transition successful, which involves keeping an open line of communication. “Talk to us, reach out to us,” Thomas said. “That’s the epiphany that we had this week in talking to folks here. I don’t want to get to 2026 and realize we didn’t encourage you to come talk to us.”

MedCon: FDA readies staff, device makers for QMSR

Related topics

Recommended content

Welcome to the new RAPS Digital Experience