GHTF Meeting Kicks Off

So said Larry Kessler, director of CDRH's Office of Science and Engineering Laboratories and the current GHTF chairman, at a press conference yesterday afternoon.FDA's Quality System Regulation and ISO 13485, the medical device quality standard used by the EU, Canada, and other countries, are as close as they have ever been to harmony, he said. And now the GHTF is implementing a system by which adverse event reports can be shared around the world in the same format. But perhaps most significantly, he said, a number of nations in Latin America and Southeast Asia will be ready to adopt quality-system schemes in the near future. In fact, a number of officials from those countries will undergo training as part of this conference. Because of the GHTF's groundwork, they will not need to build regulatory structures from the ground up -- they will just have to follow what the GHTF founding nations do. This will ease the burden on device companies that want to sell into these markets, while protecting the health of the citizens of those countries.