FDA Bitcoin related questions are cropping up as the cryptocurrency continues to gain steam. This post discusses whether the FDA accepts Bitcoin or whether Bitcoin or blockchain technologies are FDA approved.
The first question bound to bubble-up at some point – does the FDA accept Bitcoin? The short answer is, no. The FDA does not accept Bitcoin, or any cryptocurrency, as payment for a medical device, drug, or biosimilar userfee.
A number of people have also asked if Bitcoin is FDA approved. This question is more specifically asks whether blockchain has any FDA status. Blockchain is the technology underlying Bitcoin and other cryptocurrencies. It has major applications outside of Bitcoin, like recordkeeping.
Any technology, like blockchain, would need to fit into an existing category like medical device, drug, food/dietary supplement, or biologic. It is extremely unlikely to have any status outside an existing recognized category. The most likely application would be a medical device. At the time of this post (Jan. 2018) our firm is not aware of any medical device utilizing blockchain. It appears no company has approached the FDA with a product utilizing blockchain.
FDA Bitcoin questions are likely to continue. As with any novel technology, it is important to keep regulatory definitions in mind and understand when a technology may fall under FDA jurisdiction. It’s unlikely the FDA will accept Bitcoin in the future but the Agency is bound to consider some product or App using blockchain in the future.
Contact our Washington D.C. or Research Triangle offices with any questions.
**Disclaimer: Marc C. Sanchez, Esq. is a FDA attorney in private practice and the above is not intended as legal advice. FDA Atty law firm is hosting this blog solely for educational purposes.**
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