This article was originally published in The Gray Sheet
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)
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