Brian Malkin to Speak on Wearable Health Trackers at 7th ACI Advanced Summit on Medical Device Patents
Arent Fox FDA counsel Brian Malkin will be presenting “Wearable Health Trackers, FDAs ‘General Wellness’ Classification, and Patent Protection, Oh My!” at the ACI Advanced Summit on Medical Device Patents on March 1 in New York. As the sophistication of health and fitness-related technologies improves, the definition of a medical device has become less clear. In a final guidance published July 2016, FDA noted that it does not plan to actively regulate low-risk technologies that are intended only for general wellness use. Brian’s presentation will discuss FDA’s final guidance and its effects on patent prosecution strategies, market entry, and the medical device classification.
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