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    CDRH Warns Idaho Wheelchair Manufacturer for Unapproved Modifications

    The videos at 21 st Century Scientific’s website wheelchairs.com show people taking their wheelchairs off-road, in the sand and at high speeds. But the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) told the Idaho-based company in a warning letter posted Tuesday that these modifications to their wheelchairs were never approved by the agency. “Use on these terrains and functions that enable the device to lift the user, tilt the...
  • FDA Loosens Regulatory Controls on Stair-Climbing Wheelchairs

    The US Food and Drug Administration (FDA) has decided to down-classify stair-climbing wheelchairs from class III to class II medical devices, meaning they will no longer require premarket approval. Background In the US, medical devices are classified according to risk. Class I medical devices represent the least risk to patients, and are often exempt from premarket regulatory oversight (so long as they meet FDA-defined standards). Class III devices represent the oppos...