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Historically, in the absence of a 564 Declared Emergency, the FDA exercised enforcement discretion when laboratories offered laboratory-developed tests (LDTs).
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FDA's Draft Guidances for Emergency Use LDTs Spark Mixed Reactions

Public comments to the FDA’s draft guidances proposing enforcement policies for LDTs with and without a 564 Declared Emergency reveal a mix of support and opposition

Photo portrait of Julie Ballard, Principal, Carrot Clinical
Julie Ballard
Photo portrait of Julie Ballard, Principal, Carrot Clinical

Julie Ballard, principal, Carrot Clinical, is an independent clinical laboratory consultant with 25+ years of experience in helping organizations build and maintain world-class CLIA-certified and CAP-accredited clinical laboratories.

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Published:Jul 26, 2024
|3 min read
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When the FDA announced their final rule to regulate LDTs on April 30, 2024, they also issued two draft guidance documents related to enforcement policies: Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration under Section 564 and Consideration of Enforcement Policy for Tests During a Section 564 Declared Emergency

What is a laboratory-developed test (LDT)?

According to the U.S. FDA, laboratory-developed tests, or LDTs, are in vitro diagnostic products (IVDs) that are intended for clinical use and designed, manufactured, and used within a single clinical laboratory that is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and meets the regulatory requirements under CLIA to perform high complexity testing.

IVDs are devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act), including when the manufacturer of the IVD is a laboratory. IVDs are intended for use in the collection, preparation, and examination of specimens taken from the human body, such as blood, saliva, or tissue. IVDs, including LDTs, can be used to measure or detect substances or analytes in the body, such as proteins, glucose, cholesterol, or DNA, to provide information about a patient's health, including to diagnose, monitor, or determine treatment for diseases and conditions.

The former applies to certain IVDs during an immediate public health response in the absence of a declared emergency, and the latter to tests during a declared emergency.

Historically, in the absence of a 564 Declared Emergency, the FDA exercised enforcement discretion when laboratories offered laboratory-developed tests (LDTs). However, with the new LDT final rule, the FDA is phasing out the general enforcement discretion approach for LDTs. The draft guidance proposes enforcement discretion for certain immediate-response tests offered by United States government (USG) laboratories, public health laboratories, or laboratories operating under an agreement with the USG.

When there is a 564 Declared Emergency, the FDA may authorize certain unapproved medical products by issuing an Emergency Use Authorization (EUA). The FDA expects LDTs to comply with applicable requirements. In this draft guidance, the FDA describes the factors that will be considered for determining whether to issue an enforcement policy for unapproved tests LDTs.

The deadline to submit comments to ensure consideration by the FDA was July 5. About a dozen comments were submitted for each draft guidance (compared to 6,000+ comments for the proposed LDT rule). 

Comments were primarily from professional organizations representing laboratories (American Clinical Laboratory Association), medical and laboratory professionals (American Society for Microbiology and Association for Molecular Pathology), the public health sector (California Association of Public Health Laboratory Directors and San Luis Obispo Health Agency Public Health Department), as well as IVD manufacturers (Advanced Medical Technology Association Dx), and industry (Invitae, Inc.).

A mix of support and opposition

While several groups reiterated their opposition to the LDT final rule, to describing a laboratory performing LDTs as a “manufacturer,” and to classifying LDTs as medical devices, the comments support, in principle, establishing enforcement discretion in emergent situations. 

Commenters also asked for clarification of certain terms and elements. 

As drafted, those eligible for enforcement policy in an emergent situation are limited to government entities or those who have an agreement with the US government. Several commenters indicated that commercial laboratories should be included to ensure a sufficient pool of qualified laboratories to enable a faster and broader response, and to limit supply chain issues.

Related: A Timeline of Laboratory-Developed Test Regulation in the US

The draft guidance specifically states that the policy does not apply to tests with home specimen collection and at-home tests. Inclusion of self-collected specimens to mitigate spreading infectious disease and overwhelming healthcare professionals was cited by several organizations. 

AdvaMedDx stated that the guidance should apply to all test manufacturers—not only laboratories—since this is consistent with the LDT final rule stating that all IVDs, including LDTs manufactured in a laboratory, are medical devices. Limiting the guidance to single-site laboratory manufacturers would differentiate between entities manufacturing the device, which would contradict the final rule.

What are the next steps?

The FDA reviews all comments received during the public comment period, and based on the feedback, may revise the draft guidance. The revised document is then reviewed internally. When the internal review is complete, the final guidance is published. 

This process can take from several months to years depending on the number of comments received and the complexity of changes required. Based on how quickly the FDA addressed the thousands of comments for the proposed LDT rule and the relative simplicity of these draft guidances, the timeframe is more likely to be months, not years. 

The public comments for both guidances are available online: