The U.S. Food and Drug Administration issued its Final orders on granting exemptions for notification requirements of certain patient transport devices. Accordingly, firms engage in making certain permanent mounted vertical and inclined platform lifts (§ 890.3930-wheelchair elevator); and stairway chair lifts (§ 890.5150-powered patient transport) are now exempt from 510(k) requirements as long as they meet certain conditions and mitigation measures for the exemption. See Federal Register Notice 78, 14013-14017, published March 4, 2013 (the "Notice").
Pursuant to two separate petitions submitted under section 510(m)(2) of the Federal Food, Drug and Cosmetic Act, Docket Nos. FDA-2011-P-0882 and FDA–2011–P–0804, the respective petitioners satisfactorily established that the safety of such devices can be ascertained with the application of cGMP and general controls. The exemptions however do not apply to other attendant-operated devices classified under § 890.3930 or § 890.5150.
The conditions for requesting exemptions from premarket notification for vertical and inclined platform lifts classified under 21 C.F.R. § 890.3930 include: an adequate demonstration of the safety controls for prevention of free falls in the event of a device failure; as well as, an adequate demonstration of the ability of the device to withstand the rated load.
The conditions for requesting exemptions from premarket notification for stairway chair lifts classified under 31 C.F.R. § 890.5150 include: adequate demonstration of the safety controls are adequate for prevention of free falls of the chair in the event of a device failure; adequate demonstration of the ability of the device to withstand the rated load with an appropriate factor of safety; adequate demonstration of validated electromagnetic compatibility and electrical safety; and demonstration of the resistance of the device upholstery to ignition.
Despite the elimination of premarket notification requirements, manufactures of such devices should maintain and/or implement compliance programs that address these conditions for exemption to avoid unfavorable FDA actions.
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