FDA released the final rule on laboratory developed tests (LDTs) on May 6, 2024. This rule brings most LDTs under the purview of FDA through the medical device regulation by including them within the definition for in vitro diagnostics (IVDs).
The final rule includes a phased implementation by which IVDs offered as LDTs will need to meet the requirements of each phase as they come. This includes both LDTs currently used by clinical laboratories and new devices entering the market. The phases are shown in the table below:
Phase | Requirement | Deadline |
1 | Medical device reporting requirements; correction and removal reporting requirements, and complaint file quality system requirements (21 CFR 820.198) | May 6, 2025 |
2 | Requirements not covered in other phases including registration and listing, labelling, and investigational use | May 6, 2026 |
3 | Quality system requirements (21 CFR 820) | May 6, 2027 |
4 | Premarket review requirements for high risk IVDs offered as LDTs | November 6, 2027 |
5 | Premarket review requirements for moderate and low risk IVDs offered as LDTs | May 6, 2028 |
The rule also contains allowances for certain LDTs to benefit from full or partial enforcement discretion. The details of this can be found on the FDA website and were discussed in detail in our recent webinar. FDA has also launched a campaign to provide more information to industry for meeting these requirements. This includes both webinars and guidance documents. See below for links to some of the available content:
- Webinar - Final Rule: Medical Devices; Laboratory Developed Tests (held May 14, 2024)
- Webinar - Enforcement Policies for Certain In Vitro Diagnostic Devices - Draft Guidances (held June 5, 2024)
- Webinar - In Vitro Diagnostic Product (IVD): Classification (held July 16, 2024)
- Webinar - In Vitro Diagnostic Products (IVDs) - MDR Requirements, Correction and Removal Reporting Requirements, and Quality System Complaint Requirements (upcoming, August 22, 2024)
- FDA Guidance – Laboratory Developed Tests - Small Entity Compliance Guide (June 2024)
The FDA webinars and guidance documents help provide information on the rule as well as on current practices and requirements for IVDs. However, they do not go beyond the details that can be found in the final rule, leaving some unanswered questions and ambiguity for laboratories.
Many people and professional organizations in industry have been very vocal in their opposition to the final rule, with many laboratories wondering how to maintain their current test list while operating within the budgetary constraints of their organization. Many critics are also citing the final rule as FDA overreach and questioning the regulatory authority of the FDA to make and enforce such a rule.
In fact, the American Clinical Laboratory Association (ACLA) along with a private laboratory, HealthTrackRx, have filed a complaint against FDA in the U.S. District Court for the Eastern District of Texas. The complaint alleges that the FDA has exceeded its statutory authority and that the final rule represents agency regulatory overreach. It also purports that the legislation is inappropriate and ill-suited for regulating LDTs.
Within the final rule, FDA has outlined in great length its justification for the FDA authority over LDTs as well as the appropriateness of and need for the legislation. However, some legal experts think the lawsuit has merit, especially considering the implications of the recent Supreme Court decision regarding Chevron doctrine. Chevron doctrine previously mandated courts to defer to government agencies’ interpretation of ambiguous statutes. This doctrine has been overturned in a recent Supreme Court decision. As a result, rules set forth by agencies to clarify existing regulations may see increased scrutiny, and this includes the LDT final rule and subsequent ACLA lawsuits.
There is additional uncertainty regarding the FDA final rule due to the political landscape. Considering this is an election year, and FDA officials are appointed by a new president, the outcome of the election and the identity of the next selected FDA commissioner could impact the status of the final rule.
The ACLA lawsuit and current political landscape leave many laboratories wondering what steps they should be taking, hesitant to put resources toward the transition without knowing the outcome of the lawsuit. Putting off the transition could be a risky decision considering the lawsuit could take more than a year to get through the court system. Other actions by Congress to create regulations in this area (e.g. the VALID act) are expected to also take considerable time to come to fruition. With the phased transition dates starting less than one year away with medical device reporting requirements applicable starting May 6, 2025, putting off compliance could put laboratories at risk of non-compliance in the event the lawsuit is not resolved or is ruled in favor of FDA.
RQM+ recommends a conservative but strategic approach to ensure compliance with the LDT final rule should the phased implementation continue. More details regarding the content of the rule as well as strategies for compliance were discussed in our webinar held last month. If you need support for your transition, please contact our team.
💡 Watch the webinar: Adapting to the New LDT Regulatory Reality: The Path to Compliance