Time for Action on GHTF Initiatives, Chair Says

NEWS TRENDS

Implementation of guidances, improved organizational logistics, and program expansion are Larry Kessler's main goals for his term as chair of the Global Harmonization Task Force (GHTF).

Kessler, whose GHTF term runs until mid-2008, is the director of CDRH's Office of Science and Engineering Laboratories. He outlined his vision for GHTF at the AAMI/FDA International Conference on Medical Device Standards and Regulation in March. The founding members of GHTF are the United States, Canada, the European Union, Japan, and Australia.

“We have been at this for 15 years. It is time to walk the walk,” he said. “We need to develop guidance documents that will actually be used around the world.”

GHTF in particular needs to encourage single audits for multiple jurisdictions, he said. While it is unlikely that FDA's quality system regulation and ISO 13485, the inspection standard used in much of the rest of the world, will ever become totally identical, they are getting there, he said. “The latest versions suggest true harmonization is close,” he said. “One of the issues is that for companies with significant problems, 13485 doesn't help FDA take them to court. That could only change with new legislation.”

Another goal, he said, is effective operation of the national competent authority report exchange program. This would allow easy exchange of information among regulatory bodies worldwide. In particular, it could serve as a global notification of recalls and corrective actions.

The biggest priority on the logistics side is to improve GHTF's Web site, Kessler said. “We will attempt to create the definitive regulatory source for harmonization issues,” he said. “It will be in multiple languages and have translated documents.”

Several initiatives must be expanded, he said. These include the GHTF training plan and a plan to increase public availability of procedures and documents. He also noted the need for more involvement with nations in Asia and Latin America, and perhaps direct collaboration with ISO, he added.

The drug-device boundary, electronic labeling, and medical device software are among new topics that GHTF also needs to tackle. “These are new topics that will be of great concern to the device world in the future,” Kessler said. “The GHTF has a responsibility to be on the front end of new technologies. We are now close to a global regulatory model, so how can we actively push to do [more global] standards?”

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