Idea: 80% medical device kits.
80% gun kits require the buyer to perform the last 20% of the time/effort required to finish the gun. This is the threshold established by case law that separates a pile of materials and parts (which is not a gun) from a gun. Therefore these 80% kits can be sold without registering the gun with the ATF. For example:
http://gundigest.com/gunsmithing-articles/rise-80-percent-firearms
Can a similar approach be applied to medical devices? Can one sell 80% kits for medical devices without getting FDA approval?
80% gun kits require the buyer to perform the last 20% of the time/effort required to finish the gun. This is the threshold established by case law that separates a pile of materials and parts (which is not a gun) from a gun. Therefore these 80% kits can be sold without registering the gun with the ATF. For example:
http://gundigest.com/gunsmithing-articles/rise-80-percent-firearms
Can a similar approach be applied to medical devices? Can one sell 80% kits for medical devices without getting FDA approval?