Diagnostic tests that only require a few drops of blood from the fingertip. Predicting medication response and adverse drug effects (ADRs) from a simple mouth swab sample. Detecting genetic mutations linked to an increased risk of cancer, in the privacy of one’s home. As medical diagnostics have become more precise and sophisticated while significantly decreasing in cost, startup companies like 23andMe and Theranos have emerged to bring this technology to patients via direct-to-consumer testing. However, as more services are offered to patients outside of a healthcare setting, government agencies have struggled with regulating these tests and enforcing review by the Food and Drug Administration (FDA) prior to marketing. More importantly, could these tests potentially create more harm than benefit if conducted without consultation from a clinician?
Currently, diagnostic tests are classified by the FDA based on the risks associated with the device: Class I (low risk and therefore subject to the least regulatory controls), Class II (higher risk and require greater regulatory controls to provide reasonable assurance of the device’s safety and effectiveness), and Class III (highest risk and subject to the highest level of regulatory control, typically requiring FDA premarket notification [510(k)].1 Most Class I devices and some Class II devices are 510(k) exempt if they have provided a reasonable assurance of safety and effectiveness. To receive FDA clearance, device manufacturers must submit a 510(k) if the device is new or reintroduced after significant changes or modifications that may alter the existing product’s safety and efficacy. Approved medical devices are typically high-risk and undergo a more rigorous premarket review compared to the 510(k) pathway. What is notable about laboratory developed tests (LDTs) is that they are not considered by the FDA to be medical devices – but only if they are designed or manufactured completely, or partly, outside of the laboratory that offers and uses them.2