The LDT enforcement policy phase-out process under the final rule will occur in
gradual stages over a total period of four years, with premarket approval
applications for high-risk tests to be enforced by November 6, 2027. Moderate-
risk and low-risks tests are expected to be in compliance by May 6, 2028,
although FDA has stated that if premarket submissions are pending review it
will continue to exercise enforcement discretion with respect to those tests. The
FDA’s final rule is complex and, concurrently, the agency announced several
exceptions from the requirement to comply with full medical device regulatory
controls, depending upon the specific nature of the LDT and the clinical
laboratory that is offering such LDT for use by health care providers.
Publication of the LDT final rule prompted the American Clinical Laboratory
Association (ACLA) and one of its members, on May 29, 2024, and
separately, the Association for Molecular Pathology (AMP) and one of its
members, on August 19, 2024, to file complaints against the FDA in the
Eastern District of Texas and the Southern District of Texas, respectively. Both
complaints allege that the agency does not have authority to promulgate the
LDT final rule and seek to vacate the FDA’s action; the two cases were
subsequently consolidated into a single action pending in the Eastern District of
Texas. Briefing is ongoing in the consolidated case and the outcome is
uncertain. The ongoing litigation could potentially affect the FDA’s plans to
implement the steps required to phase-out enforcement discretion for LDTs,
making the implementation timeline somewhat uncertain although no
preliminary injunction has been issued to date. Accordingly, the agency has
continued its implementation efforts by actively providing guidance and training
to clinical laboratories on how to comply with medical device general controls.
Following the November 2024 federal elections, it is unclear whether the
incoming Trump Administration will continue to defend the FDA’s rulemaking
action in the consolidated litigation in Texas or if it will take steps to rescind or
modify the LDT final rule.
Affected stakeholders also continue to press for a comprehensive legislative
solution to create a harmonized paradigm for oversight of LDTs by both the
FDA and CMS, instead of implementation of the FDA’s final rule, which may be
disruptive to the industry and to patient access to certain diagnostic tests.
Ensuring compliance with the agency’s implementation plans for bringing LDTs
under the medical device framework is expected to require significant time,
financial resources, and other resources, including specialized personnel, on
the part of clinical laboratories engaged in developing and offering such
diagnostic tests. However, this FDA rulemaking was initiated after years of
failed congressional attempts to harmonize the regulatory paradigms
applicable to LDTs and other IVDs, making it unclear whether any legislative
efforts would be successful going forward. The outcome of the November 2024
elections on the composition of the 2025-2026 Congress, with both the Senate
and House transitions to Republican control, also creates uncertainties for the
diagnostic industry.
QIAGEN cannot design, manufacture or use LDTs. However, laboratories can
lawfully use QIAGEN's products, such as those for non-clinical applications,
IVDs, enzymes, or oligos, to create their own LDT workflows according to
Docket FDA-2023-N-2177 requirements
Medical devices, including IVDs, are classified into one of three classes
depending on the controls deemed by the FDA to be necessary to reasonably
assure their safety and effectiveness. Class I devices are generally exempt from
premarket review and are subject to general controls, including adherence to
the FDA’s Quality System Regulation (QSR), which describes device-specific
current good manufacturing practices, as well as regulations requiring facility
registration and product listing, reporting of adverse medical events, and
appropriate, truthful and non-misleading labeling, advertising and promotional
materials. Class II devices are generally subject to premarket notification (or
510(k) clearance), general controls and special controls, including performance
standards, post-market surveillance, patient registries or FDA guidance
documents describing device-specific special controls. Class III devices are
subject to most of the previously identified requirements as well as to premarket
approval (PMA). The payment of a user fee, which is typically adjusted
annually, to the FDA is usually required upon filing a premarket submission
(e.g., premarket notification, premarket approval application, or De Novo
classification request) for FDA review.
