FDA Does Not Regulate Smartphone Apps, But Courts and FTC Do

FDA does not treat most healthcare related smart-phone apps as medical devices, leaving it to the FTC and state regulators to regulate apps based on claims and complaints. Healthcare apps, mostly hosted on Smartphones, smart watches and other wearable devices, are popular due to high acceptance by consumers and seemingly endless possibilities. Apps can be … Read more

Off-Label Promotion Gets Political Support But Is It Good For Consumers? 

On 21 March 2017, the State of Arizona became the first state to pass the “Free Speech in Medicine Act” which allows manufacturers to practically discuss all kinds of off-label information with doctors and healthcare providers, without fear of prosecution. The day after, a similar bill, “Medical Product Communications Act, 2017”, was introduced in the … Read more