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Preamendments Class III devices

This article was originally published in The Gray Sheet

Executive Summary

FDA proposes in the Aug. 18 Federal Register to require premarket approval applications or product development protocols for lung water monitors, powered vaginal muscle stimulators for therapeutic use and stairclimbing wheelchairs. Written comments are due Nov. 16. The agency is also soliciting new information, due Sept. 2, that would justify reclassifying the devices. FDA says that it intends to require regulatory submissions within 90 days of the effective date of the final rule

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