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

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.

FDA will officially kick off the device user fee reauthorization process July 13 with a public meeting at its Silver Spring, Md., headquarters.

Leading up to the meeting, industry representatives appear to be more satisfied with the current device-review program compared to the...

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