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# Pew: Restore FDA Oversight of Lab-developed Tests
- URL: https://www.fdaweb.com/pew-restore-fda-oversight-of-lab-developed-tests/
- Published: 2021-04-29T12:00:00.000Z
- Updated: 2026-09-14T16:56:52.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5149217

Pew Charitable Trusts is calling on HHS to reinstate FDA’s authority to require premarket reviews for laboratory-developed tests. Under the previous administration, an 8/2020 HHS notice ([see earlier story](https://www.fdaweb.com/trump-lifts-lab-tests-from-need-to-get-ok-from-fda/)) removed premarket reviews for such tests, including tests to detect the virus that causes Covid-19\. The major policy change, which was made without notice and comment rulemaking, was reportedly part of HHS’ ongoing department-wide review of regulatory flexibilities enacted since the start of the pandemic and said it was consistent with several executive orders.

In a [4/28 letter](https://www.politico.com/f/?id=00000179-153b-d356-affd-3d3f64210000&ref=fdaweb.com) to HHS secretary **Xavier Becerra**, Pew complains that the Department’s move last year “not only eliminated a critical quality check on those Covid-19 tests developed by labs, but also stripped FDA’s ability to require premarket review for any LDT — whether for Covid-19 or for other areas where such tests are widely used, such as cancer and prenatal screening. This decision is extremely shortsighted given that the FDA recently evaluated 125 Emergency Use Authorization applications from labs — the main producers of LDTs — and found that among them, 82 had design or validation problemsthat needed to be addressed before they could be offered to patients.”

Additionally, Pew argues that legislation is likely needed to update FDA’s diagnostic test regulatory oversight. “There are several reasons why current diagnostics oversight is insufficient,” the letter says. “First, LDTs perform the same clinical function as commercial diagnostics,but are not held to the FDA’s standards for quality or validity. Instead, they are primarily regulated under the Clinical Lab Improvement Amendment (CLIA) regulations that govern laboratory operations.Regulatory oversight should correspond to a test’s risk and complexity, rather than where it is developed.

“Second,” Pew continues, “the lack of transparency in the diagnostics market makes it difficult to identify risky LDTs once they have been introduced. LDT developers are not required to register their tests with the FDA or publicly disclose any adverse events arising from their use. This makes it challenging for federal regulators to identify emerging risks to public health and respond appropriately. Finally, excluding a large proportion of tests from FDA review distorts the diagnostics market. Holding comparable tests to different standards based on where they are developed and used creates an uneven playing field between LDT developers and other diagnostic developers.”