FDA Official: MDUFA V funding will help global harmonization efforts

Regulatory NewsRegulatory News | October 24, 2022 | Through

Melissa Torres (left) and Augusto Bencke Geyer (right)

BOSTON, MA – A senior official at the U.S. Food and Drug Administration (FDA) said increased funding under the new Medical Device Fee Amendment Program (MDUFA V) will allow the agency to allocate more resources to the harmonization of regulations with international partners.

Melissa Torres, associate director for international affairs at the FDA’s Center for Devices and Radiological Health (CDRH), made the comments during a panel of international regulators at AdvaMed’s medtech conference, where they were moderated by moderator Diane Wurzburger, a regulatory affairs executive GE, Healthcare, and Augusto Bencke Geyer, Deputy Director General of the Office of Medical Devices at ANVISA (Brazilian Health Agency). The panel discussion also included a pre-recorded session from Paulyne Wairimu, Head of Medical Devices at the Pharmacy and Poisons Board (PPB) in Kenya.

Wurzberger noted that regulatory convergence creates opportunities to reduce time and costs for both regulators and industry, although she acknowledges that regulators have limited resources to invest in this issue. She asked the panelists if there was anything the industry could do to support regulators in advancing the topic, particularly in areas such as artificial intelligence/machine learning (AI/ML).

“We are very pleased to expand our team as part of our royalty agreements; which really highlights the importance of international harmonization,” Torres said. “We will be able to add five international affairs staff to my existing two [staff].”

She added that the agency’s goal is to further engage international partners and address global harmonization issues, including capacity building. She also noted that while the International Medical Device Regulators Forum (IMDRF) is still the Agency’s priority for the harmonization of medical devices, it is also considering other avenues, such as multilateral agreements and capacity building with others.

“These are areas that we never really had the opportunity to do [work on] in the past, and additional staff will give us those opportunities and we’re really excited to see how things play out with that,” Torres said.

During the panel, Geyer noted that while software and AI/ML have quickly become the biggest topics for ANVISA, the agency only has 50 employees in its equipment center and few have enough expertise to work on these topics. Given the limited resources available, he said his agency is more likely to reach out to other regulators, like the FDA, that already have regulations in this area to see if they can adopt those regulations for their country.

“Every time we have these discussions, we learn how to move forward,” Geyer said. “This relationship with regulators, not just IMDRF but in other jurisdictions, is very important to us.”

Aside from IMDRF’s development of premarket and postmarket guidelines to achieve harmonization across regulatory jurisdictions, Torres said she is very excited about the FDA’s Electronic Submission Template And Resource (eSTAR) pilot program, which the agency is partnering with Health Canada developed. The program is designed to allow sponsors to submit their product applications to both US and Canadian regulators through the system, reducing the administrative burden for all involved. The topic is also something Geyer is excited about, as Brazilian regulators are watching how the program is evolving.

The harmonization of different regulatory regimes is not only difficult due to a lack of resources. Regulators often face legal hurdles due to the way the laws are written in different countries.

“One of the challenges we face in the US is that our regulatory and legal framework for [the] Premarket is very different from other jurisdictions,” Torres said. “We’ve really made an effort to make some changes that allow us flexibility internationally.”

“Until we get some of these changes, we’re pausing some of this work, but that doesn’t mean we’re not thinking about how we can still harmonize premarket testing,” she added.

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