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....)
-Wes
I don't think the problem is with surgeons using the device for off-label purposes. The problem is when the companies market them for off-label purposes. An important distinction, no?
ReplyDeleteLarry Husten
www.cardiobrief.org
Larry -
ReplyDeleteThe issue is one of "equivalency." Is a right-sided catheter ablation procedure sufficiently "equivalent" to a left sided procedure? In the past, the FDA has suggested (and CMS's payments for these procedures as a result substantiates) that they were sufficiently "equivalent."
Suddenly now, given the current interpretation of the 510K rule in court, it seems devices used on one side of the heart safely may not be necessarily used on the other side of the heart safely, and therefore may not be marketed for left-sided indications. How much more money will it add to the prices of devices to insist on so much more testing accross the board for all cardiac devices like this?
The FDA has a responsibility to come clean on how to interpret their own rules.
My cousin had Maze procedure performed at MacNeal Hospital in western subs of Chicago. Dr. P ( unfortunatly I can not spell his name ) is amazing. He did his bypasses and Maze procedure in 3 hours and in 3 days he went home.
ReplyDeleteNever had atrial fibrillaition since. Doctors should have an ability to use devices they deemed usefull for them and no beauracrats should be telling them what use and what not.