Lab industry seeks more flexibility in FDA emergency enforcement guidance

The laboratory-developed test (LDT) industry and infectious disease clinicians called on the US Food and Drug Administration (FDA) to broaden guidance on enforcement discretion during a declared public health emergency and in immediate response to an emerging health threat to encourage the development of more diagnostic testing options.

In May 2024, FDA published draft guidance describing the enforcement policy for certain laboratory manufacturers that offer unauthorized in vitro diagnostic devices (IVDs) as an immediate response to a chemical, biological, radiological, or nuclear (CBRN) threat in the absence of a declared public health emergency. A second draft guidance spelled out when the agency would consider an enforcement policy for tests developed during a declared public health emergency.

The two draft guidance documents were released alongside the agency’s controversial final rule for laboratory developed tests, which amends FDA regulations to treat all IVDs as medical devices (RELATED: FDA issues long-awaited LDT final rule, Regulatory Focus 29 April 2024).

Immediate response guidance

The draft guidance outlining FDA’s enforcement policy for certain laboratory manufacturers that offer unauthorized IVDs as an immediate response to a CBRN threat in the absence of a declared public health emergency was needed because FDA is phasing out its general enforcement discretion approach for LDTs under the LDT final rule.

In comments to the agency, the American Clinical Laboratory Association (ACLA) continued to assert that FDA lacks the authority to regulate LDTs under its medical device authorities but offered comments on the draft guidance in the event that the final LDT rule is upheld in court and implemented by the agency. ACLA said the draft guidance on immediate response tests would limit which clinical laboratories can offer tests in response to an emerging health threat. Specifically, ACLA disagrees with FDA’s approach of displacing other enforcement discretion policies that were established with a public health rationale.

“The LDT Final Rule already has introduced confusion for laboratories regarding whether they can introduce new testing services, and the Immediate Response Test Draft Guidance only adds to that confusion, which slows down development and availability for much-needed tests,” ACLA wrote.

ACLA also called on FDA to clarify that the immediate response draft guidance applies to commercial laboratories and that laboratories will not be excluded “for minor compliance infractions that do not affect their ability to develop and offer reliable tests.” They also asked for more information on what is means to have an agreement with the US government.

Additionally, ACLA urged the agency to expand the policy to allow the sharing of test protocols among laboratories that have common ownership, to include labs that have developed tests approved by the New York State Clinical Laboratory Evaluation Program if they use the same underlying technology, and to include tests that use at-home specimen collection devices that are consistent with cleared or approved intended uses.

AdvaMedDx, a division of the Advanced Medical Technology Association, called on FDA to broaden the guidance to include all IVD manufacturers instead of limiting it to laboratory manufacturers. The regulation of diagnostic tests should be based on the risk associated with the test rather than the entity developing it, AdvaMedDx commented.

“In this case, it is arbitrary to propose a policy establishing special rules for single-site laboratory manufacturers, particularly given the track record that other IVD manufacturers have demonstrated in being able to quickly develop and validate tests to meet emerging public health threats. It would be more supportive of public health to facilitate rapid deployment of the most reliable tests from experienced developers, regardless of whether they are a single-site laboratory or an IVD manufacturer that produces and provides tests to laboratories,” AdvaMedDx wrote.

The Association of Public Health Laboratories (APHL), which represents state and local public health labs, cautioned FDA to be sure the guidance does not “limit testing and exposure mitigation efforts.” APHL asked for clarification on FDA requirements including the acceptable validation criteria and emergency use authorization submission packages. The group also urged FDA to allow other ways of demonstrating the ability to develop sensitive and specific diagnostic tests other than having a history of FDA cleared, approved, or authorized tests since most public health labs do not have that experience with the FDA.

Declared emergency guidance

FDA also issued draft guidance outlining the factors the agency plans to consider when deciding to issue an enforcement policy for test manufacturers that offer unapproved tests during a future declared public health emergency.

APHL advised FDA to consult with them and the US Centers for Disease Control and Prevention (CDC) when considering an LDT enforcement discretion policy. “APHL member laboratories are the tripwires that alert the rest of the public health and healthcare community to health threats; they and the CDC are the foundation of the National Laboratory System,” APHL commented. “They will be able to advise FDA on the public health response and bring the laboratory perspective on the need for accelerated testing, test risk potential, availability of appropriate alternative tests, and the availability of sufficient mitigations to address risks of false results.”

APHL also urged FDA to explicitly state in the guidance that it would not object to the modification and implementation of a cleared or authorized test if the modification did not change the indication for use described in the original 510(k) or emergency use authorization.

The Infectious Diseases Society of America (IDSA), which represents infectious disease clinicians and scientists, urged FDA to consider regional impacts when there may be an early cluster of disease where the rapid expansion of testing is necessary.

“During the mpox outbreak of 2022, testing was delayed because the Centers for
Disease Control and Prevention (CDC) was tracking cases and testing capacity at a
national level and did not adequately account for local needs in places like New York
City that saw early spikes in cases. To facilitate adequate regional and local
consideration, IDSA recommends that the guidance be amended to include FDA
consultation with state and local health departments and clinicians in affected areas,” the group wrote.

The American Society for Microbiology (ASM) suggested that FDA broaden the factors that it will consider during a public health emergency. For example, the agency should consider the specimen type, volume of tests submitted, and performance of available diagnostics.

“ASM agrees that ensuring accuracy of diagnostic tests is essential to patient safety, high-quality patient care, and the effectiveness of public health interventions. However, these guidelines as written do not fully account for the uniqueness of each situation and the integral and complementary roles of public health/clinical laboratories and commercial manufacturers in combatting both local and national public health issues,” the group wrote.

Comments on immediate response guidance

Comments on declared emergency guidance

Lab industry seeks more flexibility in FDA emergency enforcement guidance

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