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In Brief: FDA reg revocation

This article was originally published in The Gray Sheet

Executive Summary

FDA reg revocation: Agency publishes final rule in July 19 Federal Register eliminating regulations on warning and caution statements for: denture reliners, pads, and cushions; denture repair kits; infrared generators (including heating pads); insulin syringes; mechanical massagers and vibrators; steam or turkish baths; and ultraviolet generators. The rule also removes a section of device regs relating to pessaries for intracervical and intrauterine use, which FDA says "can be more appropriately given as statements of policy," and to professional and patient labeling for intrauterine contraceptive devices, which the agency believes "is no longer necessary because these devices are no longer being marketed"...
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