FDA Official: MDUFA V funding will help global harmonization efforts

Regulatory NewsRegulatory News | 24 October 2022 |  By 

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

BOSTON, MA – A top US Food and Drug Administration (FDA) official said that increased funding in the new Medical Device User Fee Amendment (MDUFA V) program will allow the agency to put more resources toward harmonizing regulations with international partners.
Melissa Torres, associate director for international affairs at FDA’s Center for Devices and Radiological Health (CDRH), made the remarks during a panel of international regulators at AdvaMed’s The Medtech Conference, where she was joined by moderator Diane Wurzburger, a regulatory affairs executive at GE Healthcare, and Augusto Bencke Geyer, deputy general manager of the medical devices office at ANVISA (Brazilian Health Regulatory Agency). The panel also featured a pre-recorded session from Paulyne Wairimu, head of medical devices at Kenya’s Pharmacy and Poisons Board (PPB).
Wurzberger noted that regulatory convergence creates opportunities to reduce time and costs for both regulators and industry, though she acknowledged that regulators have limited resources to invest in the issue. She asked the panelists whether there was anything that industry could do to help regulators advance the topic, especially in areas such as artificial intelligence/machine learning (AI/ML).
“We are thrilled that within our user fee agreements we will be able to able to expand our team; really highlighting the importance of international harmonization,” said Torres. “We will be able to obtain another five employees working on international affairs to add to my two existing [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 medical device harmonization, it is also looking at other avenues, such as multilateral agreements and capacity building with other.
“These are areas that we never really had the opportunity to [work on] in the past and having additional staff will allow us those opportunities and we’re really excited to see where things will go with that,” said Torres.
During the panel, Geyer noted that while software and AI/ML have quickly become some of the biggest issues for ANVISA, the agency only has 50 people working at its device center, and of only a few have enough expertise to work on those topics. With the limited resources available, he said his agency tends to look to other regulatory agencies, such as FDA, that have already issued regulations in that area to see if they can adopt those regulations for their nation.
“Every time that we have these discussions, we learn on how to progress,” said Geyer. “This relationship with regulators, not only IMDRF, but in other jurisdictions are very important to us.”
Aside from developing premarket and postmarket guidelines through IMDRF to bring harmonization across regulatory jurisdictions, Torres said she’s very excited about FDA’s electronic Submission Template And Resource (eSTAR) pilot program that the agency is developing with Health Canada. The program is intended to allow sponsors to submit their product applications through the system to both US and Canadian regulators to reduce administrative burdens for everyone involved. The issue is also something Geyer is excited about, as Brazilian regulators are watching to see how the program develops.
Harmonizing different regulatory regimes is not only difficult due to lack of resources. Regulators often face legal hurdles due to how the laws are written in different countries.
“One of the challenges we have within the US, is that our regulatory framework and legal framework for [the] premarket is much different than other jurisdictions,” said Torres “We have been really striving to try to make some changes that allow us flexibility internationally.”
“Until we get some of those changes, we're putting a pause in some of that work, but it doesn't mean we're not thinking about ways to still harmonize premarket review,” she added.


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