What are you creating Dr. Frankenstein?
When Dr. Frankenstein undertook the creation of his subject it was a well-intentioned misadventure. His attempt to create something beautiful and extraordinary ended up being something hideous and unmanageable which sought to kill others. Dr. Frankenstein had made something reprehensible and dangerous to mankind.
While FDA's attempts to create a package of data that will protect the American public is laudable and well-intentioned, their involvement often results in data requests involving over-sized parts and pieces, unnecessary to the creation of the being (dataset) to ensure it is safe and functionally works. FDA's requirements are substantially delaying and many times killing innovations beneficial to patients. No matter what the quality and quantity of the data submitted by a 510(k), many reviewers seem to believe it is never correct, sufficient, or adequate...Read More