Stair-climbing wheelchairs

Petition seeking the reclassification of the devices (21 CFR 890.3890) from Class III to Class II is submitted to FDA on Sept. 2 by the Washington, D.C. law firm of Barnes, Richardson & Colburn on behalf of Garaventa Ltd. The petition cites as justification the development of published standards since FDA initially classified stair-climbing wheelchairs. With the request, FDA must consult with an advisory panel and publish a notice denying the request or announcing its intent to initiate a proceeding to reclassify the devices within 60 days of its Aug. 18 call for premarket approval applications or product development protocols ("The Gray Sheet" Aug. 24, In Brief)