FDA Exempts Platform and Stairway Chair Lift Devices from Premarket Notification
The Food and Drug Administration issued orders granting exemptions for premarket notification requirements for stairway chair lift (here) and inclined/vertical platform lift devices (here), subject to certain conditions. Effective March 4, these devices may be distributed without a letter of…
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substantial equivalence from FDA. Conditions for the exemption include appropriate analysis and testing and restraints to prevent the user from falling.