Hearing aid reg revisions may be shelved due to de-regulatory political climate.
This article was originally published in The Gray Sheet
Executive Summary
IOL INVESTIGATIONAL DEVICE EXEMPTION REGS ON FAST TRACK as FDA's device rulemaking agenda tacks to the right. As part of an effort to speed publication of rules seen as easing regulatory burdens, FDA is pushing to issue a final rule revoking a special IDE rule for intraocular lenses. The effort reflects calls from Congress and outside groups for relaxation of device regulations.