FDA Intends to Speed Up Approval of Medical Devices

The FDA conducts studies and grants approvals for innovative medical devices in much the same fashion as it does for new drugs. Although the approval process for a new drug can take up to 12 years in research and development and cost well over a billion dollars before the FDA gives its approval, the approval process for devices used for cosmetic enhancements like liposuction technology, lasers and the like, tends to be even longer, requiring at least 10 months just for the first round of investigation by the FDA, that of confirming that the device is a “first-of-a-kind,” and not just a slightly-altered version of another device.  

An article in Bloomberg Businessweek reported on a new system at the FDA, called the Innovation Pathway, that intends to shorten the time for first-of-a-kind devices from 10 months to 5 months. The first product assigned to this new system is a brain-controlled, prosthetic arm created by the military.

Alhough th US is considered a powerhouse in the development of new drugs and other technologies, our country is the 7^th slowest nation when it comes to approving medical devices, lagging way behind Israel, India and European countries like France and Germany. Unlike the US, most European countries’ regulatory processes are much more supportive of innovation, while still ensuring consumers that what they approve meets the tests of safety and effectiveness. The Innovation Pathway program is the first attempt in 35 years to shorten the approval time for devices.

Technology will continue to move as quickly as the FDA will allow it, bringing us newer and better devices for liposuction, breast reconstruction and breast enhancements, and all kinds of laser skin treatments. I’m delighted that the FDA has taken this step and look forward to faster approvals for medical devices of all kinds, both for reconstruction and for cosmeteic purposes. It’s a needed step in the right direction.

To your health & beauty,
Dr. Joe Danyo