FDA pulls out of medtech forum over divergent perspectives

The US Food and Drug Administration (FDA) has withdrawn its membership in the Global Harmonization Working Party (GHWP) that largely represents Asian regulators. The agency said it decided to leave the organization after being sidelined on key issues.

Jeff Shuren, director of FDA’s Center for Devices and Radiological Health (CDRH), wrote a letter to GHWP Chair Jinghe Xu on 27 November announcing that FDA was leaving the group because it was not able to voice its concerns about how the group was developing medtech guidelines. He told Xu, who is also deputy commissioner of China’s National Medical Products Administration (NMPA), that FDA initially joined GHWP in December 2021 to help align GHWP regulations with that of the International Medical Device Regulators Forum (IMDRF), which mostly represents regulators from Western and developed countries.

When FDA joined the group, agency officials did not realize just how divergent GHWP’s regulatory direction was compared to FDA and IMDRF, Shuren said. While they’ve tried to raise concerns in the group, he said FDA has been sidelined and unable to address them.

“I would like to see GHWP and IMDRF collaborating on the common goals of fostering global regulatory convergence and leveraging resources to make safe and effective medical devices available globally, not trying to compete with one another,” Shuren wrote. “FDA’s goal in joining GHWP was to provide a bridge between the two organizations. Unfortunately, GHWP does not offer the opportunity for FDA and other regulatory bodies to have our voices heard and considered.”

In particular, Shuren said that GHWP’s leadership lacked diversity or global representation in important areas, and sufficient representation of regulator perspectives. He also noted there was a lack of alignment and transparency when developing documents, and duplication of documents from other organizations that led to inconsistencies.

Nicole Ellis, a CDRH spokesperson, echoed those sentiments to Focus, noting that much of GHWP’s work either duplicated what was being developed or had been completed by IMDRF, which caused confusion and misalignment with the work other regulators had done. She also said that the public consultation process was inconsistent, which meant not all stakeholder feedback was taken into consideration when developing documents.

“Much of the work in GHWP is driven by industry and not regulators,” Ellis added. “Unfortunately, we didn’t see any progress in bridging the gap between GHWP and IMDRF despite multiple attempts to work together between the organizations.”

FDA plans to reassign staff who were working on GHWP issues to work on IMDRF efforts. Moving forward, the agency’s global medtech harmonization efforts will primarily take place through its IMDRF work.

Despite the decision to leave GHWP, Shuren invited Xu and GHWP to participate in next year’s IMDRF meeting hosted by FDA in Washington, DC.

“As chair of IMDRF in 2024, I will continue IMDRF’s efforts to work collaboratively with as many entities as possible, including GHWP, the World Health Organization, Pan American Health Organization, African Medical Devices Forum, etc., to ensure alignment of medical device international harmonization efforts,” Shuren wrote. “In your role as GHWP Chair, I would like to invite you to attend the March IMDRF meeting to continue the discussions between GHWP and IMDRF and to provide the GHWP update at the meeting.”

Besides the US, GHWP represents 32 members, of which 27 are located in Asia. In contrast, IMDRF represents 11 regulatory regimes including the US, European Union, Canada, China and Brazil. It also has affiliate members representing regulators in countries including South Africa, Chinese Taipei, Egypt and Israel.

FDA letter to GHWP

FDA pulls out of medtech forum over divergent perspectives

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