- The Food and Drug Administration's (FDA) proposed rule would change decades of Laboratory Developed Test (LDT) regulation by expressly considering these in vitro diagnostics (IVDs) medical devices.
- LDT companies would need to comply with medical device statutes and regulations including submission requirements, manufacturing standards, and user fees.
- FDA plans to phase out its LDT enforcement in stages beginning in 2024 and ending in 2028.
FDA published a proposed rule that would regulate IVDs, including LDTs, as medical devices, drastically altering the regulatory landscape for LDTs. The proposed rule would update the definition of IVDs in 21 CFR § 809.3 to explicitly include that IVDs, including LDTs, are medical devices as defined in Section 201(h)(1) of the FDCA.
FDA reasons that the landscape has changed since the Medical Device Amendments of 1976 were enacted– e.g. LDTs are more complex, may be run in large volumes for patients from different institutions, and are used more frequently for guiding critical healthcare decisions. The agency has identified tests it characterizes as "problematic LDTs" that are promoted with false or misleading claims and whose unreliable results may lead to delayed, foregone, or unnecessary treatment. The proposed rule specifically mentions questionable tests for heart disease and cancers. FDA's concerns with LDTs were heightened during the COVID-19 pandemic, but the agency contemplated LDT regulation long before the pandemic began.
Under the proposed rule, LDTs would be subject to traditional medical device requirements, including premarket submission requirements for class II or class III medical devices, quality system (QS) regulations, medical device reporting, registration and listing, and more. LDTs would also be subject to medical device user fees, including annual registration fees, fees for premarket applications/submissions, and annual fees for periodic reporting for class III devices.
Once the rule is in effect, FDA plans to phase out its current enforcement discretion regarding LDTs across a 4-year period. FDA cautions that the phaseout policy does not in any way alter the fact that it is illegal to offer IVDs without complying with applicable requirements and FDA retains discretion to pursue enforcement action at any time against violative IVDs when appropriate. The phase out will occur in stages according to IVD categories:
- High-risk – IVDs that are subject to premarket approval requirements.
- Moderate-risk – IVDs that may be eligible for classification into class II.
- Low-risk – IVDs that may be eligible for classification into class I.
A description of the proposed stages is as follows:
- Stage 1: End the general enforcement discretion approach with respect to medical device reporting (MDR) requirements and correction and removal reporting requirements one (1) year after FDA publishes a final phaseout policy, which FDA intends to issue in the preamble of the final rule.
- Stage 2: End the general enforcement discretion approach with respect to requirements other than MDR, correction and removal reporting,and premarket review requirements two (2) years after FDA publishes a final phaseout policy.
- Stage 3: End the general enforcement discretion approach with respect to QS requirements three (3) years after FDA publishes a final phaseout policy.
- Stage 4: End the general enforcement discretion approach with respect to premarket review requirements for high-risk IVDs three and a half (3½) years after FDA publishes a final phaseout policy, but not before October 1, 2027.
- Stage 5: End the general enforcement discretion approach with respect to premarket review requirements for moderate risk and low risk IVDs (that require premarket submissions) four (4) years after FDA publishes a final phaseout policy, but not before April 1, 2028. FDA stated that it would not intend to enforce against IVDs offered after a 510(k) or De Novo request has been submitted (within the 4-year timeframe) until FDA completes its review of the submission.
For certain categories of LDTs, FDA is proposing to continue to apply the current general enforcement discretion approach going forward. The continued enforcement discretion would extend to 1976-Type LDTs, Human Leukocyte Antigen (HLA) tests, tests intended solely for forensic (law enforcement) purposes, and tests exclusively used for public health surveillance activities.
The agency set a 60-day comment period for the rule and mentioned it is seeking feedback in specific areas. These areas include a grandfathering approach for currently marketed LDTs, whether specific enforcement discretion policies would be appropriate for IVDs offered as LDTs for future public health scenarios, and what, if any, unintended consequences may result from the proposed phaseout policy to certain patient populations. FDA is also considering whether academic medical center laboratories (AMCs) that operate under unique circumstances would justify a different regulatory approach.
On a call discussing the proposed rule, FDA Center for Devices and Radiological Health (CDRH) Director Jeffrey Shuren remarked that FDA is open to working with Congress, specifically mentioning the VALID Act, but the agency is expressly asserting and explaining its oversight over LDTs through this proposed rule.
Comments are due by December 2, 2023. Foley Hoag is available to provide assistance with drafting comments and understanding the implications of the proposed rule. Interested clients of the firm will be receiving a more detailed analysis of the proposed rule within the coming days.
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