While the LDT Final Rule includes a phased approach for most tests, certain tests fall outside the scope of this phaseout approach. For these tests, enforcement discretion will still apply. In this post, we’ll identify these tests, discuss the implications for laboratories, and offer guidance on navigating this aspect of the LDT Final Rule.
Identification of Tests Outside the Scope
Which Tests Are Exempt?
The FDA has identified specific tests that are exempt from the phaseout approach. These include tests used in public health emergencies, certain rare disease tests, and some other specific categories. It’s crucial for laboratories to determine whether any of their tests fall into these categories.
Impact on Laboratories
For laboratories, the exemption of certain tests means that enforcement discretion will continue to apply, allowing for some flexibility in compliance. However, it also requires careful monitoring of regulatory updates to ensure ongoing compliance with FDA expectations.
Enforcement Discretion
What Does Enforcement Discretion Mean?
Enforcement discretion allows the FDA to exercise flexibility in enforcing certain regulations for specific tests. This means that while the regulations exist, the FDA may choose not to enforce them strictly for particular tests, often to facilitate access to critical diagnostics in specific situations.
Implications for Laboratories
For laboratories, enforcement discretion means:
- Continued Monitoring: Laboratories must stay informed about which tests are subject to enforcement discretion and any changes to these policies.
- Documentation and Justification: It’s essential to maintain thorough documentation and justification for the use of tests under enforcement discretion to demonstrate compliance if needed.
- Proactive Communication: Engaging with the FDA and other regulatory bodies proactively can help clarify expectations and ensure ongoing compliance.
Understanding the tests that fall outside the phaseout approach and the implications of enforcement discretion is crucial for laboratories. By maintaining thorough documentation, staying informed about regulatory updates, and engaging with regulatory bodies, labs can navigate this aspect of the LDT Final Rule effectively.
In our final post, we will discuss strategies for preparing for the future of LDTs and offer final thoughts on the LDT Final Rule.
Stay tuned for more insight and practical advice on adapting to the LDT Final Rule.