The US Department of Health and Human Services (HHS) on August 19 published a sweeping announcement, Rescission of Guidances and Other Informal Issuances Concerning Premarket Review of Laboratory Developed Tests, in which it stated that the Food and Drug Administration (FDA) would not require premarket review of laboratory developed tests (LDTs) without notice-and-comment rulemaking. The announcement has implications not only for LDTs intended for SARS-CoV-2 testing, but also for LDTs intended for other purposes, such as pharmacogenetic testing and direct-to-consumer testing.
Historically, FDA has not actively regulated most LDTs under a longstanding policy of enforcement discretion. FDA defines an LDT as an in vitro diagnostic test that is designed, manufactured, and used within a single clinical laboratory certified for high complexity testing under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). FDA has stated that it reserves the right to regulate certain LDTs if FDA determines such oversight may be required to protect the public health. For example, FDA previously has taken enforcement action against LDTs intended for pharmacogenomic testing.
More recently, in response to the coronavirus (COVID-19) pandemic, FDA has required clinical laboratories that develop and use diagnostic LDTs for SARS-CoV-2 (including molecular and antigen tests) to submit an EUA for such tests. However, as described in FDA’s guidance document, Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency, FDA has allowed laboratories to offer testing using such LDTs before receiving EUA authorization, provided that the laboratory validates its LDT, notifies FDA of the LDT validation and its intent to start testing, and submits an EUA within 15 business days of such notification. Further, FDA’s guidance permits laboratories developing serology LDTs for SARS-CoV-2 antibody testing to offer testing using such LDTs without seeking an EUA, as long as the laboratory validates its serology LDT, notifies FDA of the test validation, and complies with certain labeling requirements.
HHS’s brief announcement states that HHS has determined that FDA will not require premarket review of LDTs without formal notice-and-comment rulemaking, “as opposed to through guidance documents, compliance manuals, website statements, or other informal issuances.” HHS notes that this announcement is consistent with President Donald Trump’s executive orders aimed at reducing administrative regulation and is based on “HHS’s ongoing department-wide review of regulatory flexibilities enacted since the start of COVID-19.” However, the language in the announcement restricting FDA’s ability to require premarket review for LDTs is not specifically limited to COVID-19-related LDTs.
HHS further notes that laboratories developing LDTs continue to remain subject to regulation by the Centers for Medicare and Medicaid Services (CMS) under CLIA. Further, laboratories that opt to use COVID-19-related LDTs without EUA authorization or any other FDA premarket review would not be eligible for PREP Act liability immunity. As described in our prior Lawflash, the PREP Act provides immunity from personal injury, business disruption, or property damage claims, except willful misconduct.
Although no longer required, laboratories may voluntarily submit to FDA an EUA application or other premarket submission for their COVID-19/SARS-CoV-2 LDTs, and FDA will continue to review such submissions. Laboratories that have already received EUAs for their COVID-19-related LDTs are not affected by the announcement.
Impact on COVID-19-Related LDTs: Although the recent HHS announcement could be viewed as a rebuke of FDA’s oversight for COVID-19-related LDTs, as a practical matter, it is unclear how significantly the announcement will affect accessibility for LDT testing.
Impact for Other LDTs: The HHS announcement also could have implications for LDTs that are not intended for COVID-19-related purposes. As noted above, FDA has previously taken enforcement action against LDTs intended for pharmacogenetic testing, asserting that such LDTs require FDA premarket review. Additionally, FDA has previously stated that its policy of enforcement discretion for LDTs does not extend to LDTs intended for direct-to-consumer testing. Although the context of the HHS announcement is focused on COVID-19, the specific language could be read more broadly to suggest that FDA cannot require premarket review for any LDTs without notice-and-comment rulemaking. However, even if the intent of the HHS announcement is to more broadly restrict FDA’s premarket review authority for LDTs (not just for COVID-19), FDA can still take enforcement action for LDTs where it determines the promotion or labeling for the LDT is false or misleading.
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