On January 13, 2017, the Food and Drug Administration (FDA) released a discussion paper concerning an updated proposed framework for oversight of laboratory developed tests (LDTs). According to FDA, the updated proposal is the result of ongoing engagement with industry stakeholders. Under the proposal, the FDA generally stands by its position that a complementary risk-based oversight framework that involves both the FDA and the CMS Clinical Laboratory Improvements Amendments (CLIA) program is the preferable alternative to a CMS-only framework. However, the updated proposal generally scales back FDA’s involvement in the framework and emphasizes the need for regulatory flexibility.
FDA’s new discussion paper does not represent the formal position of FDA, nor is it enforceable. The paper is meant merely to “advance the public discussion” by providing “a possible approach to spur further dialogue.”
Do not let this disclaimer (or the upcoming change in White House administration) dissuade you from reading the new paper. Change is coming for LDTs and diagnostics generally, regardless of who is in the White House. If your business relates in any way to LDTs and diagnostic tests currently regulated by FDA, then we suggest taking the time to read FDA’s updated proposed oversight framework and considering how this could impact your business operations and projections over the next decade and beyond.