The FDA has announced a plan is in the works that could possibly speed up the approval of new medical devices and ultimately deliver better quality of life for many patients. The plan is called Innovation Pathway and the goal would be to review first-of-a-kind medical devices in a five month time period. Currently, the review period is almost twice that long, taking 10 months (or sometimes longer).
But under this new program there would be better correspondence between device scientists and the FDA starting in the early stages of development. This type of communication would aid in helping scientists construct studies that showcase both the effectiveness and safety of new devices.
The executives at medical device companies have been saying for a while that it takes the FDA twice as long to review and approve the devices as similar agencies do in Europe. The U.S. lags behind other countries in this regard and is ranked the seventh lowest nation in terms of approval. Countries such as France, Germany, Israel, and India have much quicker approval rates.
This could have global ramifications since medical devices represent a $350 billion business worldwide, and most of the major companies are based in the U.S.
The first device to benefit from the new system or plan put forth by the FDA is the innovative prosthetic arm developed by the Department of Defense. It has a remote link to a microchip in the brain and could possibly deliver near-natural coordination of the prosthesis. This device is intended for patients with a spinal cord injury, amputation, or stroke.
Once the manufacturer of these types of medical devices have been accepted into the new FDA program, they’ll receive a written agreement from the FDA that states a target approval date plus a blueprint for how and when the product will be reviewed. Experienced scientists and managers within the FDA will make up the special reviewing committee.
While it's certainly admirable that the FDA is trying to overhaul its 35-year-old system for approving medical devices, public safety advocates believe more changes are needed. Specifically, they feel there needs to be guidelines that specify when the FDA can revoke a device's approval. Obviously, lobbyists within the medical device industry have opposed that type of change. Over the past several years device firms such as Boston Scientific Corp. and Johnson & Johnson have been forced to recall faulty devices and have come under the watchful eye of Congress.
In the meantime, patients who are relying on American-made medical manufacturers will benefit from the FDA's Innovation Pathway plan. When you consider the numerous times the FDA has been in the hot seat, this kind of good PR has been a long time coming.