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# HHS Should Reverse LDT Policy: House Committee
- URL: https://www.fdaweb.com/hhs-should-reverse-ldt-policy-house-committee/
- Published: 2021-05-13T12:00:00.000Z
- Updated: 2026-09-14T16:58:50.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5149313

The House Energy and Commerce Committee leadership has written to HHS secretary **Xavier Becerra** urging that he reverse the Trump administration HHS decision to remove FDA authority to require premarket review of Covid-19 laboratory-developed tests (LDTs). The 5/11 [letter](https://energycommerce.house.gov/sites/democrats.energycommerce.house.gov/files/documents/Letter%20re%20Reversing%20Trump%20Administration%20LDTs%20and%20FDAs%20Policies.pdf?ref=fdaweb.com) says that at the time former HHS secretary **Alex Azar** made the decision, the committee leaders said it “raised questions about the reliability of tests on the market and threatened to alter our understanding of Covid-19 outbreaks and the progression of the pandemic.”

While FDA has typically exercised enforcement discretion for LDTs, the letter says, allowing such tests to come to market without prior review, FDA has maintained that it has jurisdiction over the tests.

The representatives review the history of the Trump administration’s actions and say the “long winding path of regulatory uncertainty has been misguided from the start. The former FDA commissioner and career scientists at FDA reportedly opposed the move, telling HHS officials that the decision could lead to inaccurate tests flooding the market…. We ask that you take steps to ensure the quality of these tests by reversing the Trump administration’s misguided policy on LDTs and restoring FDA’s premarket review authority.”