October 9, 2017
Partner August Horvath
was quoted in the International Devices & Diagnostics Monitor
article “What You Can and Can't Say in Advertising Devices.” The article discusses challenges medical device makers face when making sure their advertising materials are not false or misleading. "It's obvious that the FDA is not as used to regulating medical devices as it is to regulating drugs,” August noted. “They don't provide as much guidance for medical devices, and you have to apply the logic that you would use for a drug to the device."
“But unlike drug makers, device makers don't have to submit advertising to the FDA at the time of dissemination, so there's no pre-approval process. This sounds like freedom, but instead it can be a burden for device makers,” he said.