But if the surgeon wants to use a device that heats the tissue non-invasively to create non-conducting lines in the atrium, that's not okay in the eyes of the law because it isn't labeled for that use specifically for use in the left atrium by the FDA, even though the FDA approved (one example) the device for medical use.
You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.Does anyone else find that strange?
Using the current analogy, most of the catheters we've been using for years to ablate left-sided arrhythmias percutaneously aren't approved specifically for that use either, but rather right atrial type I flutter (See here or here, for example).
Uh, oh, sorry... (just trying to make a few hundred thousand dollars as a whistleblower....)