The Food and Drug Administration (FDA) announced today that it intends to regulate Laboratory Developed Tests (LDTs) furnished by clinical laboratories as medical devices and outlined a plan to end enforcement discretion for all LDTs over the next 4 years. These proposed new FDA regulatory requirements would be in addition to the comprehensive regulations applicable to LDTs and laboratories under the Clinical Laboratory Improvement Amendments (CLIA). Thus, it is critical that, if finalized, FDA avoid hindering patient access to critical test results, mitigate the additional regulatory burden on already regulated clinical laboratories that have long been the leading edge of advancing precision medicine in patient care, and establish the necessary regulatory clarity and flexibility to address the critical differences between laboratory procedures and distributed kits.
The magnitude of the task that FDA is proposing to undertake in regulating all LDTs as traditional medical devices cannot be overstated. To avoid hindering patient access to critical tests results, clinical laboratories must be given ample notice and clarity as to how to come into compliance with such vast new regulatory burden. However, the timelines in the proposed rule appear inadequate for reasonable regulatory compliance of this scale. FDA’s limited capacity for premarket review and inspection of non-COVID tests during the pandemic demonstrated that FDA would require far more resources than currently appropriated to develop and implement such a framework. Moreover, the absence of grandfathering provisions imposes unreasonable retrospective requirements for already marketed LDTs.
LDTs have long been the leading edge of advancing precision medicine in patient care. Thus, even prospective compliance with the existing medical device regulations will require substantial FDA regulatory flexibility, which is inconsistent with the historically rigid case-by-case approach the agency has employed during FDA premarket reviews of LDTs submitted voluntarily to the agency. Far greater creativity, clarity and transparency will be needed to avoid the substantially increased threat of laboratory facility closures and the corresponding risk of a significant decline in the development and availability of new innovative testing options for patients.
Moreover, the proposed FDA rule intends to overlay an existing regulatory framework designed not for laboratory procedures, but for medical devices. Clinical laboratories will not be able to comply with the additional FDA medical device regulations in the absence of clear guidance on how rules designed for distributed medical devices would be applied to laboratory procedures. Yet, critical questions remain about how FDA’s proposed requirements will be able to address the critical differences between laboratory procedures and distributed kits consistent with FDAs least burdensome principles. For example:
- How will FDA define which activities performed in laboratories do not constitute the FDA regulated laboratory test “device?”
- How does FDA intend to apply its quality systems rules, which are intended for manufacturing facilities, to laboratories that do not distribute products?
- How will FDA manage conflicting regulatory requirements with respect to the use of clinical laboratory test results without risking prosecution for violations of FDA “off-label” promotion rules?
FDA has worked with legislators and stakeholders for several years on the appropriate regulatory framework and the Coalition for 21st Century Medicine remains committed to that effort. While the Coalition believes new legal authority is necessary and a legislative approach more appropriate, the Coalition plans to submit public comments on the FDA’s proposed rule and continue its longstanding approach of working with FDA policymakers to ensure critical regulatory flexibility necessary to avoid interruption of patient access to new and innovative LDTs.
About C21
The Coalition was formed in 2006 with the mission of working with the FDA to develop the appropriate regulatory pathway for advanced diagnostic tests that promote innovation and protect public health. We represent the world’s most innovative diagnostic technology companies, clinical laboratories researchers, physicians, and venture capitalists -all linked by a common mission: to develop and commercialize state of the art diagnostics that improve patient health.
The Coalition acknowledges that some groups have questioned whether FDA currently has the authority under the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 301 et seq.) to regulate LDTs as medical devices, including the subset of LDTs that FDA sought to define for discussion in draft FDA guidance as In Vitro Multivariate Index Assays (IVDMIAs). Consistent with the approach that the Coalition has taken throughout consideration of this issue, the Coalition’s comments supportive of certain approaches to regulation should not be considered an acknowledgement by the Coalition or any of its members that FDA currently has the authority to regulate laboratory services as medical devices. In addition, these comments do not represent an admission by the Coalition or any of its members that any particular laboratory service is a “device” as that term is currently defined under Section 201(h) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 321(h)).
For press inquiries, contact hmurphy@c21cm.org.