Selling Medical Device DTC in FL - Need a license?

#1
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
 
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#2
Are you a medical device manufacturer or just a provider (like a distributor)? Or both? The FL law you reference is in regards to providers, but your question specifies manufacturers. If you are a manufacturer you will need to comply with the FDCA and FDA regulations, and depending on your device that process can be more or less extensive.
 
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