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Device Reg Issues In Play As FDA Kicks Off User Fee Renewal Effort

This article was originally published in The Gray Sheet

Executive Summary

FDA will host a public meeting July 13 to hear public input in advance of agency-industry negotiations to reauthorize the device user-fee program. Industry appears to feel better about the device-review program than it did during the prior user-fee program, but what the top issues will be during negotiations this time around remain to be seen. Ongoing reform efforts in Congress will impact the process.

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