Laboratory-Developed Tests (LDTs) offer patients the potential for preventing disease, obtaining early diagnoses, and receiving the most accurate and best course of treatment from their health care providers. Any regulatory process to oversee LDTs must appreciate the promise these tests hold without stifling innovation, while simultaneously ensuring patient safety and the accuracy, reliability, and reproducibility of LDTs.
FDA LDT Homepage
Access background information, notices about public meetings, and archived webinars
FDA Releases Discussion Paper on Oversight of LDTs
November 23, 2016
FDA Drops Guidances for LDTS
AAB/NILA Comments on the FDA Draft Guidance