I am reviewing the rules for selling medical devices in Florida. It appears that the state requires 'home medical equipment" manufacturers that sell directly to consumers to have a license to sell in the state. It defines "home medical equipment" to be" any product as defined" by the FDCA - so that's pretty broad! Does mean any medical device manufacturer selling directly to patients must have a license? Such as blood glucose mfrs, bandaid mfrs, etc.?
You can find the FL laws for this at http://www.flsenate.gov/Laws/Statutes/2016/400.93
You can find the FL laws for this at http://www.flsenate.gov/Laws/Statutes/2016/400.93