House Subcommittee Debates Device Remanufacturing Definition, Sends User-Fees Bill to Next Stage

"Proponents of the remanufacturing bill are looking to better distinguish between medical device remanufacturing, and servicing or repairs, saying it would improve patient safety."

Why this is important: Getting a simple oil change on a vehicle is certainly not the same as rebuilding the car after an accident. In some instances, repairing accident damage may be significant enough to result in a vehicle being reclassified as “salvage” on its title documents – or otherwise voiding a manufacturer warranty. The title is branded to put future buyers on notice that significant alterations have been made to the vehicle and that it may not work the same as before the accident. The same guiding principles should apply to medical devices.