AdvaMed wants diagnostic regulatory reforms in FDA user fees renewal

[Image courtesy of Amazon]

The Advanced Medical Technology Association (AdvaMed) and diagnostic test manufacturers, labs, health care nonprofits and industry associations are asking federal lawmakers to pass diagnostics regulations as part of the FDA Safety and Landmark Advancements (FDASLA) Act of 2022.

The proposed diagnostic test regulations — outlined in the Verifying Accurate, Leading-edge IVCT Development (VALID) Act — would increase FDA’s oversight of laboratory-developed tests (LDTs), treating them more like medical devices with a risk-based approach. The VALID Act would require pre-market review for diagnostic tests that have a high risk of serious injury or death due to treatment decisions based on inaccurate results.

“The current federal approach to oversight has fueled regulatory uncertainty that jeopardizes investment in the next generation of diagnostics that will provide for im…

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