MedTech Dive March 8, 2024
Melissa Torres, CDRH’s associate director of international affairs, spoke about the importance of the International Medical Device Regulators Forum and how countries are struggling with AI oversight.
For nearly 13 years, countries have collaborated on medical device guidance to develop a common set of standards for regulators around the world. The work has been part of the International Medical Device Regulators Forum (IMDRF), which will meet next week in Washington, D.C.
Members include the European Union, Japan, Canada, Australia and the U.S., and the World Health Organization is an official observer. The group has developed guidance documents and discussed topics ranging from early questions such as what is a medical device to how countries can regulate new technologies like artificial...
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