Interest in LDT Oversight Returns to Congress but Stakeholders’ Views Largely Unchanged

With the US Food and Drug Administration (FDA) likely in coming weeks to release its final rule on regulation of laboratory-developed tests (LDTs), Congress has indicated interest in once again taking up oversight of such tests and reforming diagnostics regulation.

This month, US Sen. Bill Cassidy, R-La., issued a Request for Information (RFI) asking stakeholders for input on diagnostics reform. Also this month, the House of Representatives’ Energy and Commerce (E&C) committee held a public hearing on “Evaluating Approaches to Diagnostic Test Regulation and the Impact of the FDA’s Proposed Rule.”

Source: https://www.360dx.com/policy-legislation/interest-ldt-oversight-returns-congress-stakeholders-views-largely-unchanged