In a jaw-dropping move, HHS announced today that, effective immediately, FDA will no longer require premarket review of laboratory developed tests (LDTs)—including LDTs to detect the virus that causes COVID-19—absent notice and comment rulemaking. HHS is rescinding all guidance documents and informal statements of policy concerning LDTs. HHS said that it made this decision “as part of the HHS’s ongoing department-wide review of regulatory flexibilities enacted since the start of COVID-19” and consistent with Executive Orders 13771 (Executive Order on Reducing Regulation and Controlling Regulatory Costs) and 13924 (Executive Order on Regulatory Relief to Support Economic Recovery). HHS offered no further explanation for this abrupt about-face. Nor did HHS explain why this new approach was not extended to other FDA policies that have increased regulation and regulatory costs for companies seeking to offer COVID-19 tests (see our previous post here).
As a consequence of HHS’ decision, clinical laboratories will no longer be required to submit a request for emergency use authorization (EUA) before offering LDT-based testing for COVID-19. The announcement does not alter clinical laboratory obligations under the Clinical Laboratory Improvement Amendments (CLIA).
According to the announcement, clinical laboratories may still voluntarily seek an EUA from FDA for COVID-19 tests, and laboratories that offer such LDTs without premarket authorization will not be eligible for PREP Act coverage. As discussed in a previous post, the PREP Act provides immunity from liability for losses related to medical countermeasures used to combat a declared public health emergency. The liability immunity applies to entities involved in the development, manufacture, testing, distribution, administration, and use of such medical countermeasures. Clinical laboratories that have already obtained an EUA (or other marketing authorization) for an LDT are not affected by this announcement.
As readers of the blog know, we have long been critical of FDA’s limitations on LDTs (see, e.g., prior posts here, here, here, here, and here). HHS’s announcement has far-reaching implications for all clinical laboratories offering LDTs, which we will explore in future blog posts.