Laboratory-developed tests (LDTs) are tests done on human samples such as blood, saliva, or tissue to check for diseases or health conditions [1]. They are designed by, manufactured in, and used in the same single clinical laboratory [2]. In vitro diagnostic tests are sold to diagnostic laboratories, clinics, and other users. They must be pre-validated. In contrast, LDTs are not licensed or sold and are often developed by a clinic out of necessity. LDTs have become increasingly more widely used than in the past and are now used to make important decisions about patient care.
In 2024, FDA finalized its ruling that IVDs are medical devices, and with this ruling, FDA decided that it will begin stricter regulatory requirements for LTDs [3, 4]. Beginning May 6, 2025, LDT sponsors must comply with medical device reporting [3]. By May 6, 2026, LDT sponsors will need to comply with medical device registration, listing, labeling, and investigational use regulations [3]. By May 6, 2027, LDT sponsors must have compliant quality systems [3]. By November 6, 2027, sponsors will need to comply with premarket reviews for high-risk LDTs [3]. Lastly, by May 6, 2028, sponsors will need to comply with premarket reviews for moderate-risk and low-risk LDTs [3].
When the FDA makes regulatory changes, it can be difficult to adapt. If you utilize LDTs, EMMA International can help you maintain compliance with changing regulations. If you have never dealt with med device regulations, it can be confusing and stressful. EMMA International is well-versed in creating regulatory strategies and adapting existing systems to comply with new regulations in a timely manner.
EMMA International is here to provide full-circle solutions for all aspects of medical device regulatory compliance. Give us a call at 248-987-4497 or email us at info@emmainternational.com to learn more about how EMMA International can take the stress out of quality and regulatory compliance!
[1] FDA (2024) In Vitro Diagnostics, Retrieved on 18 November 2024 from: https://www.fda.gov/medical-devices/products-and-medical-procedures/in-vitro-diagnostics
[2] FDA (2024) Definitions and General Oversight: Laboratory Developed Tests FAQs, Retrieved on 18 November 2024 from: https://www.fda.gov/medical-devices/laboratory-developed-tests-faqs/definitions-and-general-oversight-laboratory-developed-tests-faqs
[3] FDA (2024) Laboratory Developed Tests, Retrieved on 18 November 2024 from:
https://www.fda.gov/medical-devices/in-vitro-diagnostics/laboratory-developed-tests#oversight [4] Taylor (2024) FDA prioritizes guidance on lab developed tests in 2025 plan, Retrieved on 18 November 2024 from: https://www.medtechdive.com/news/fda-guidance-lab-developed-tests-2025/729820/
