An international group of medical device regulators, the Global Harmonization Task Force, is giving the boot to industry representatives.
The founding regulatory bodies of the group, formed to hammer out global standards for medical devices, decided to terminate the organization and start over — without trade groups as members.
The U.S. Food & Drug Administration and the regulatory agencies of the European Union, Japan, Canada and Australia make up the GHTF. The group was founded in 1992 in “an effort to respond to the growing need for international harmonization in the regulation of medical devices," according to its website.
"[F]or the past 18 or so years [the GHTF] has worked on the development of a regulatory model and supporting documents to underpin globally harmonized regulation of medical technologies," Medical Technology Assn. of Australia CEO Anne Trimmer wrote on her organization’s website. The MTAA represents the medical device industry Down Under.
To date, she wrote, "industry associations have participated on an equal footing with regulators," adding that the new organization will consult with interested groups, including industry, healthcare providers and patients.
The soon-to-be-former trade association GHTF members plan to compose a response to the regulators’ action at their next meeting in Brisbane, Australia, in May, according to Trimmer.
