FDA eases up on stair-climbing wheelchairs

The FDA relaxes oversight of stair-climbing wheelchairs, no longer demanding clinical trials for new devices.

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.

Food & Drug Administration (FDA)

News Well, 510(k), Food & Drug Administration (FDA), Pre-Market Approval (PMA), Regulatory/Compliance

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