MedCon: FDA ramps up for transition to QMSR

COLUMBUS, OH – The US Food and Drug Administration (FDA) is working to finalize its proposal to align its device Quality System Regulation (QSR) with the international standard ISO 13485:2016, creating the Quality Management System Regulation (QMSR).

In preparation for the final rule, the agency is readying for the change internally by updating its technology systems, training staff and replacing the Quality System Inspection Technique (QSIT).

“If you’ve ever seen a 483 form, list of observations about inspections, you know that we have databases from which we pull citations and observations that are connected to the regulation, the current [21 CFR Part] 820. So, all of that has to change,” Karen Masley-Joseph, senior advisor in the Office of Medical Device and Radiological Health Operations in FDA’s Office of Regulatory Affairs, told attendees at the 2023 MedCon conference, sponsored by the AFDO/RAPS Healthcare Products Collaborative and FDA.

FDA is also revising any regulations, policies, procedures and other documents that will be impacted by the QMSR rulemaking. There are some documents that require changing out a few words or references, while others will require substantial revision related to inspections and reviews.

“The range on how the policies and procedures need to get updated is from very minor or major,” Masley-Joseph said.

Implementation timeline and comments

Keisha Thomas, associate director for compliance and quality in the Office of Product Evaluation and Quality at the Center for Devices and Radiological Health (CDRH) did not forecast a specific date for releasing the final rule, noting that it’s slated for publication by December 2023, though she pointed out that the Spring 2023 agenda is just around the corner. The regulators also declined to provide an update on whether the one-year proposed implementation timeline is different in the final rule. However, Thomas said that was a top issue in public comments received on the proposed rule.

Thomas said she was surprised to see a split in the public comments from the medical device industry, with some commenting that the proposed one-year implementation period was not long enough, and others saying that one year was sufficient.

While the comment period on the proposed rule is closed, FDA is still responding to questions about the rule via email ([email protected]). “You do get a real person. It’s a person that’s actually involved in what’s happening,” Thomas said.

Training and QSIT

Staff training is at the top of the to-do list for FDA and CDRH. While the requirements of the ISO 13485 are substantially similar to the current regulations, the language is different and creates a learning curve, Masley-Joseph said (RELATED: QMSR: FDA proposes QSR overhaul after years of delays, Regulatory Focus 22 February 2022).

The training is also a challenge because the FDA is already dealing with agency-wide issues of staff attrition, retirement, and onboarding new staff. “There’s a lot for us to do with limited resources,” said Thomas.

As part of the transition to the QMSR, CDRH will also be replacing the Quality System Inspection Technique (QSIT), first launched in 1999. Masley-Joseph said a lot has changed since the QSIT was first launched in 1999 so this is an opportunity to think about how to do inspections effectively and how to use resources efficiently. The QSIT will be sunset on the effective date of the QMSR final rule. “There will be a new program. That is currently in development,” Masley-Joseph said.

Finally, the FDA is preparing for a significant communications push to explain the rationale behind the change and its expected impact, Masley-Joseph said.

MedCon: FDA ramps up for transition to QMSR

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