Gentlemen,
I have also been very interested in the future directions of GHTF. I find their guidance extremely practical.
On April 23, FDA issued a report called "
Global Engagement" that might help us understand the new direction. On page 23 it states:
Since 1992, device regulators and industry from the European Union, United States, Canada, Australia, and Japan have worked collaboratively under the Global Harmonization Task Force (GHTF) to achieve greater uniformity in national medical device regulatory systems. For example, to promote global harmonization of approaches to regulating unique device identification (UDI) systems for medical devices, GHTF developed a framework (published in September 2011) that GHTF members are encouraged to follow when regulating these systems in their countries. Global harmonization of UDI systems helps regulatory authorities respond swiftly and effectively to protect public health when a problem is discovered with a particular device.
Through liaison with other countries and involvement of observer organizations, GHTF also works to foster awareness and adoption by developing economies of GHTF documents and harmonized regulatory practices measures.
GHTF is aiming, by the end of 2012, to complete its regulatory documents and finalize a regulatory model that can be used by developing economies. During 2012 to 2013, GHTF will transition to a new format, the International Medical Device Regulators Forum (IMDRF), with a focus on maintaining the harmonized documents. IMDRF will comprise an expanded membership of regulatory bodies, observer organizations, and related communities that share a common goal of achieving greater international uniformity and convergence in regulatory practices for medical devices.
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Karen Long RAC
Regulatory Affairs Manager
Vancouver BC
Canada
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Original Message:
Sent: 04-24-2012 15:12
From: Alexander Gaffney
Subject: GHTF
Bill,
Thank you for your attention to this story. To the best of my knowledge, the GHTF is indeed morphing into the International Medical Device Regulator's Forum, which is looking to assume the entirety of its duties. (See my 15 March story on the IMDRF).
However, I am under the impression the organization is currently in the process of finishing up several outstanding documents that have been under development. The guidance referenced today was one such document.
If you--or anyone else--has any information that contradicts this, please let me know so I can use discretion when approaching future GHTF stories.
Best,
Alec
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Alexander Gaffney
- RAPS
agaffney@raps.org
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Original Message:
Sent: 04-24-2012 14:43
From: William White
Subject: GHTF
The latest RF Today calls attention to a document just issued by the GHTF. I am confused. I was under the impression that the GHTF had been disbanded in favor of the creation of a harmonization group made up of only regulatory authorities. If you are aware of additional details on this subject, I would be interested to learn.
Bill
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William White
Senior Consultant
Quality System Strategies LLC
Elkhart IN
United States
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