Discover the FDA’s final rule on Laboratory Developed Tests (LDTs) and its implications for regulatory compliance. Learn how BioBoston Consulting can support your laboratory in navigating these changes.
There have been major developments within the landscape for Laboratory Developed Tests (LDTs) following a final rule issued by U.S. Food and Drug Administration (FDA). It brings a sea of changes from the prior hands-off policy, making LDTs unequivocally subject to regulation as medical devices. With laboratories across the country wrestling with how to navigate these new changes, learning what can be disrupted and what should change, including clarification on the rule’s pertinent points is essential to maintaining compliance and continuing to provide services.
Final Rule Tips and Takeaways
But the core of the final rule is to clarify all In Vitro Diagnostics (IVDs), including LDTs, are treated as medical devices under FDA regulations. The enhanced definition attempts to demonstrate applicability in quality and safety across all diagnostic tools. In light of this, the FDA has announced it will begin using enforcement discretion for various IVD categories (i.e., certain tests developed in health care systems to serve patient populations with a particular need or for previously marketed tests) to aid a smoother transition. The time limit on this discretion will be gradually removed over four years, indicating that the body is clearly moving towards more onerous regulation.
Define In Vitro Diagnostics:
Including clarification that IVDs are a subcategory of medical devices, as well as including LDTs in the definition. Consistent quality and safety standards for diagnostic tools.
Enforcement Discretion:
Allows minimal discretion for certain IVD categories to aid in the transition process.
Certain labs are given time to fully comply.
Impact on Laboratories
This has left in its wake a new regulatory landscape where no lab is exempt from quality standards related to medical devices. This means creating or updating quality systems that are in line with FDA expectations. Deployment of these quality systems into daily practices often requires operational changes (from documentation upgrades to process overhauls).
Regulatory Compliance:
LDTs will need to conform with the medical device regulation. The discovery, conducted nationwide, implicates other labs as well: All must clean up their quality systems to comply with standards from the FDA.
Quality: Setting up or reinforcing the quality systems is now mandatory. Actions contemplated on the operational front for inculcating fresh quality demands are necessary
Submission of New Drug Application (NDA)
The sponsor company files an NDA with the FDA after a successful Phase III trial. The submission contains the safety and efficacy data of the drug, manufacturing information with labels and usage in proposed stages. The NDA is then reviewed by the FDA to determine if the drug’s benefit-risk profile supports approval.
Operational changes
This will involve changing your operation under the necessary rules.
Extensive changes to documentation, processes and systems may be necessary.
The more regulated the data is, the greater operational costs for labs as they add systems and skills to meet regulatory standards. The hard part is reconciling the imperative to produce novel diagnostic answers within the constraints of regulation. This also provides potential growth for regulatory consultancy in guiding laboratories through these changes.
Conclusion
The FDA’s final rule represents a sea change in Laboratory Developed Test regulations and is based on the principle that laboratories should be held to standards that assure patient safety and test reliability. In this evolving environment labs must evolve or close to stay compliant and competitive. BioBoston Consulting is prepared to provide ongoing support for the laboratory process with knowledge in all stages from preclinical development to commercialization.
Get in touch with BioBoston Consulting right away or go to our website now and learn more about how we can help your organization.
