On October 3rd, 2023, the U.S. Food and Drug Administration (FDA) published a proposed rule to clarify and confirm that in vitro diagnostic products (IVDs), including certain laboratory developed tests (LDTs), are considered devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act), regardless of whether the IVD is manufactured by a laboratory. Where an LDT is an IVD but developed by a laboratory, the proposed rule seeks to establish a clear regulatory pathway for these tests, ensuring they meet the same safety and effectiveness standards as other IVDs. Historically, the FDA exercised enforcement discretion over most LDTs but the risks associated with most modern LDTs are much greater than in the past. Thus, in addition to the proposed rule, the FDA has also proposed a policy to phase out its enforcement discretion approach toward LDTs in favor of greater oversight. The FDA’s increased oversight is aimed to address the concern that LDTs are increasingly relying on high-tech instrumentation and software, being performed in large volumes, and being used more frequently to help guide critical health care decisions.
Relevant stakeholders must stay apprised of the status of the proposed rule and its potential impact on their business practices and be aware of how to submit their comments on the proposed rule through the public comment process.
Key Elements of the Proposed Rule:
- Clarifying the definition. The FDA has provided clarification on the definition of a “device” to reflect that the FD&C Act does not differentiate between entities manufacturing a device, even if such an entity is a laboratory. Therefore, LDTs will be governed as IVDs.
- Phase Out of Discretionary Approach: The FDA intends to implement a five-stage, four year “phase out” of its general enforcement discretion approach for LDTs, such that enforcement of LDTs as IVDs will increase over time until they are governed with the same enforcement approach as other IVDs.
- Stage 1: End the general enforcement discretion approach with respect to MDR requirements and correction and removal reporting requirements one 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, QS, and premarket review requirements two years after the FDA publishes a final phaseout policy.
- Stage 3: End the general enforcement discretion approach with respect to QS requirements three 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 half 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 years after FDA publishes a final phaseout policy, but not before April 1, 2028.
- Submission of Comments: Stakeholders seeking to comment on FDA’s proposed rule may do so until December 4, 2023.
How Frier Levitt Can Help
In addition to general comments, the FDA is requesting comments on the proposed approach as well as alternative solutions that will be considered prior to the publication of a Final Rule. Frier Levitt can assist interested parties to submit comments on the proposed rules, and upon publication of a final rule, counsel relevant laboratories and/or manufacturers on maintaining compliance during the discretionary “phase out” period and after. Contact Frier Levitt for assistance in preparing and submitting comments to FDA regarding the proposed rule or for guidance to ensure compliance once the rule has been finalized and published.
