To Regulate or Not? Perspectives on FDA Regulation of Non-OEM Service
Mon. April 10: 11:30am-12:45pm
The FDA is considering oversight for services performed by entities other than the OEM on an FDA-regulated reusable medical device. While it is impossible to predict the specific outcome from the FDA’s research, there are a fairly discrete number of options and each requires some level of preparation. This session will provide an overview of the situation, OEM and non-OEM perspectives, and suggested action items for HTM professionals.