Senate User Fee Bill Includes Measures To Reform LDT Regulation

By Kelly Lienhard / May 18, 2022 at 7:23 PM
The Senate’s recently released draft user fee legislation seeks to give FDA authority over laboratory-developed tests by creating a risk-based regulatory framework for LDTs, as well as setting up a user fee program for in-vitro clinical tests. The House version of user fee legislation that passed out of the Energy & Commerce Committee on Wednesday (May 18) does not include LDT provisions, but House lawmakers indicated they would like to see LDT provisions added before the bill goes to a...

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