FDA officials ruled this month to lighten the regulatory burden for stair-climbing wheelchairs, dubbing them a lower-risk device with an easier path to the U.S. market.
Regulators downgraded the devices from the highest-risk Class III category to Class II labeling, allowing new stair-climbing wheelchairs to submit for clearance through the FDA’s fast-track 510(k) pathway rather than submitting to the more stringent premarket approval process.
The FDA’s Orthopedic and Rehabilitation Devices Panel met late last year to discuss the downgrade, and voted in favor of more lax controls and redefined the device category to include more methods of propulsion. The panel settled on the following definition: "A stair-climbing wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device is intended to climb stairs."
The panel further discussed various areas of potential patient risk, including everything from possible falls to skin rashes and the possibility of electric shock.
The panel ultimately decided that stair-climbing wheelchairs do not qualify as life-supporting or -sustaining technologies, ruling that the moderate oversight of a 510(k) review is sufficient to evaluate new technologies.
The downgrade did not come without criticism. One "representative of a patient advocacy coalition" asked the FDA not to loosen oversight of the technology, warning that "this change in classification would result in greater risk for some of our nation’s most vulnerable consumers."
