FDA Subject To More Oversight Following User Fee Bill Passage
This article was originally published in The Gray Sheet
The legislation, awaiting the signature of the president, will bring greater scrutiny of device center activities by Congress and industry.
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The House Energy and Commerce Committee Democrat says few in-depth member talks about user-fee bills have taken place because of a focus on Affordable Care Act repeal and replacement.
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.
Device industry advocates stressed to CDRH during a meeting last week that draft-guidance documents need to more routinely be finalized or withdrawn in an expedited manner, and that agency staffers must resist using the out-for-comment document as if they are settled policy.