QMSR is Live: Expert says new rule may be challenging for smaller firms, combination product makers

Medical device makers must comply with the US Food and Drug Administration’s (FDA) Quality Management System Regulation (QMSR) after the rule took effect on Monday. Additionally, FDA inspections of device facilities will no longer be conducted under the prior Quality System Inspection Technique (QSIT) and instead will be carried out in accordance with a new compliance program manual.

Medtech companies that don’t have experience marketing products outside the US, 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 inspectors 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 February, 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 won’t 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, won’t be greatly burdened because the base of the program is ISO 13485.

However, Trautman noted that small companies focused on marketing in the US and companies making combination products may have more difficulty complying with the new regulation because they’re 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 doesn’t apply to them because FDA has a separate compliance program for combination products. However, she noted that the 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 audit and enforce the new regulatory system. To shed more light on its thinking, FDA published its medical device compliance program manual on 30 January 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 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 inspectors 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.”

FDA compliance program manual

QMSR is Live: Expert says new rule may be challenging for smaller firms, combination product makers

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