MedCon: ORA official discusses Class I recalls, RRA, QMSR, reorganization

COLUMBUS, OH – The number of Class I recall events for medical devices has increased over the last decade, a trend that is concerning experts at the US Food and Drug Administration (FDA).

Class I recall events “are the ones that concern us. They consume our resources as an agency and as an industry,” Anne Reid, program director of the Office of Medical Devices and Radiological Health Operations (OMDRHO), Office of Regulatory Affairs (ORA) at FDA, told attendees as part of an update on OMDRHO and ORA during the 2024 MedCon conference, sponsored by the AFDO/RAPS Healthcare Products Collaborative and FDA. “Those are the things that can cause harm or death, and it’s a grave concern for us that these things keep trending upwards. We're very concerned about Class I.”

The top three root causes of a Class I recall include process control, device design, and nonconforming material, Reid said. In particular, medical devices lead the number of recalled products in fiscal years 2012 through 2024, with a total of 32,336 recalls occurring over that time period compared to product types such as food and cosmetics (26,184 recalls), drugs (16,137 recalls), and biologics (11,605 recalls).

RRA

As part of the Consolidated Appropriations Act in 2023, the agency’s authority to conduct remote regulatory assessments (RRA) was expanded to include devices and Bioresearch Monitoring (BIMO). Reid said FDA is beginning to use that authority, shifting away from the voluntary system of remote interactive engagement with industry developed during the COVID-19 pandemic.

FDA also recently published draft guidance for industry about how they conduct RRAs, Reid noted, which includes information on how and why FDA may decide to use an RRA over an in-person visit.

“Our goal after the pandemic was to actually get out and be in person,” she said. “But we are using this in places where we can’t physically get to an inspection.”

Preparing for QSMR

FDA is taking steps to implement the Quality Management System Regulation (QMSR) following the publication of the final rule and the frequently asked questions document earlier this year, Reid said.
“You're going to hear from CDRH and ORA over the next couple of years before launch about what you can do and how to prepare,” she said.

At FDA, staff are implementing new technology systems, changing to new language, and adopting the new citation system, Reid said, as well as developing relevant regulations, policies, procedures, and a compliance program. “We know that the requirement’s substantially similar, but the language is going to change,” she said. “So, it's going to be ISO language. Now it's going to look a little different.”

FDA staff are also undergoing training, and developing standard operating procedures, work instructions, and templates in addition to building communications systems for internal and external stakeholders.

“I've been telling my own investigators and compliance officers and recall coordinators and everyone in my program: please go read the rule,” Reid said. “Understand the language of the rule. It's different, but read it.”

FDA reorganization change process

Reid said FDA is still in the clearance phase of its reorganization change process, which involves “a lot of things, including congressional notification and bargaining with our unions.”

Although she admitted she couldn’t share much, “we will be different, and it is a huge reorganization,” Reid said.

For those concerned about the change coming, Reid said that any large organization eventually undergoes change. “FDA of today does not look like the FDA of the early 1900s,” she said. “Imagine if we still looked like that. So, change was going to come one way or another.”

From an external perspective, FDA might not change all that much, Reid noted. “You will still have, probably for most people, the same people you talk to today are the same people you'll talk to later on,” she said.

MedCon: ORA official discusses Class I recalls, RRA, QMSR, reorganization

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