In case you missed GHTF's closing statement [PDF], the GHTF Archive page at imdrf.orgb makes it rather clear:
"Important! The organisation GHTF no longer exists, and has been permanently replaced by the IMDRF. All material appearing on this page and the pages within has been moved here from the old GHTF site for preservation, and is no longer current. It is historic information and should not be acted upon."IMDRF was launched earlier this year as the regulators-only successor to GHTF. So, unlike GHTF (a blend of agency regulators and industry representatives), IMDRF relegates industry to a consultation role. IMDRF members include a who's who of global regulators: the U.S. Food and Drug Administration (FDA), Australia's Therapeutic Goods Administration (TGA), Brazil's National Health Surveillance Agency (ANVISA), Health Canada, the European Union (EU), Japan's Pharmaceuticals and Medical Devices Agency (PMDA), and the Asian Harmonization Working Party (AHWP).
IMDRF looks build on - not ignore — the work of GHTF. Makes sense since GHTF's existing body work of GHTF already covers most areas of medical device regulation, is widely used, and may be updated as regulatory needs change. While the goals themselves are not set to change, the pace of change and the way in which harmonization occurs is sure to get revamped.
Hopefully, in the next decade, or sooner, the IMDRF will begin the process of harmonizing areas of the international medical device regulatory arena so medical device manufacturers won't have to deal with varying regulations throughout the world. Onward and upward, GHTF - eh, IMDRF!
[Hat tip to Leo Eisner!]
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