What a Biden Administration Might Portend for Regulation of Laboratory Developed Tests
The roller coaster that has become FDA regulation of laboratory developed tests (LDTs) is about to get even more topsy-turvy now that Joseph Biden has been elected President of the United States. Here’s a look at where things stand and what we might expect from the Biden administration. FDA Review of LDTs One of the new administration’s first orders of business will be to ensure a robust pipeline of COVID-19 molecular, antibody and antigen tests. To accomplish that objective, the Biden FDA will likely consider the reversing the controversial LDT policy changes recently announced by the Trump administration. In August, HHS announced that the FDA would no longer require premarket review for LDTs but that labs could still voluntarily seek approval, clearance or emergency use authorization (EUA). But in October, the FDA pulled the rug out by announcing that it would no longer perform EUA review of COVID-19 LDTs so that it could concentrate its resources on “innovative” new tests in the interests of public health. The announcement came as a stunner, particularly since many of the most innovative new COVID-19 tests were LDTs from companies like Abbott and LabCorp. And it’s not just COVID-19. The policy shift reversing the […]
- Establishment of a technology certification program for lower-risk tests;
- Requirement that high-risk tests undergo premarket review to verify analytical and clinical validity;
- Authority of the FDA to require that any test undergo premarket review after providing the developer an opportunity to address issues identified by the agency; and
- Creation of a new system to allow hospitals and labs to submit their tests electronically to the FDA for approval, a move that would speed up the approval process and increase the quality and reliability of the testing, according to the bill summary.
- Reform that recognizes diagnostics as separate and distinct services from medical devices, and that also distinguishes between LDTs and in vitro devices;
- Grandfather and transition policies that protect patient access to currently available lab tests; and
- A regulatory system that balances the needs of innovation and appropriate regulatory oversight to ensure the accuracy, reliability and access of these tests.
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