The FDA’s LDT regulations have been long in the making since the release of draft guidance, “Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories: Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs),” in 2014. Since then, we have seen multiple proposed changes and also a legislative process beginning in 2018 with introduction of the Diagnostic Accuracy and Innovation Act (DAIA) and then introduction of multiple versions of the Verifying Accurate and Leading-edge IVCT Development (VALID) Act. These legislative efforts did not come to fruition, and the FDA moved forward with the rule-making process. The FDA finalized and published the rule on May 6, 2024, with an effective date of July 5, 2024. In this blog, we will explain the impact of the LDT regulations in simple terms in the form of a Q&A.
Q: What is the LDT rule?
A: The LDT rule is primarily one line with significant impact. The rule amends the FDA’s regulations to make explicit that IVDs are devices under the FD&C Act, including if the manufacturer is a laboratory.
Q: Does this mean that LDT companies need to follow all device regulations immediately?
A: No, the agency has established a phase-out policy and a few exemptions under continued enforcement discretion.
Q: What is the phase-out policy?
A: The phase-out policy is the gradual implementation consisting of five phases within four years and ending on May 6, 2028.
Q: What are these five phases?
A: These phases are as follows:
Q: What are some of the exemptions under continued enforcement for certain LDTs?
A: Exemptions can be divided into two categories:
Category 1: Continued general enforcement discretion for the following:
Category 2: Enforcement discretion for pre-market review: (Please note that Phases 1, 2, and 3 are still applicable):
Q: Our LDT is already on-market as of May 6, 2024. What does our organization need to do to comply with the LDT rule?
A: Your organization will be required to comply with Phases1, 2, and 3 for the LDT rule starting with MDR, Correction and Removal, and Complaints Files from May 6, 2025 onward. Your organization may also need to develop change control procedures and systems to review product changes to make sure that product changes after May 6, 2024, are in compliance with the rule. If these changes are significant, then you may need to meet pre-market review requirements.
Q: What types of procedures and system does my organization need to have in place to review significant changes?
A: We recommend reviewing the FDA guidance on “Deciding When to Submit a 510(k) for a Change to an Existing Device” and incorporating some of the decision flow charts as a part of your standard operating procedure (SOP) for product changes. Any changes that trigger submission of a new 510(k) may be considered significant.
We will provide additional information about each phase in future blogs. Please follow us on LinkedIn. You can also reach us at info@altaq.com or contact us if you have any questions or are wondering if your organization needs support in meeting these requirements.
