Medical Devices; Immunology and Microbiology Devices; Classification of the High Throughput DNA Sequencing for Hereditary Cancer Predisposition Assessment Test System
Key claim: FDA is placing high-throughput DNA sequencing tests that assess hereditary cancer risk into Class II with special controls, a less burdensome path than Class III that is meant to keep the tests reasonably safe while making them easier to bring to patients.
Abstract
(Rule · Health and Human Services Department, Food and Drug Administration) The Food and Drug Administration (FDA) is classifying the high throughput DNA sequencing for hereditary cancer predisposition assessment test system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the high throughput DNA sequencing for hereditary cancer predisposition assessment test system. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the safety and effectiveness of the device. We believe this action will also enhance patients’ access to beneficial innovative devices, in part by reducing regulatory burdens.
Why this matters
Hereditary cancer risk sequencing panels are increasingly used to guide screening, surgical, and treatment decisions, and FDA’s Class II classification lowers the regulatory bar for new entrants while codifying special controls intended to keep results reliable. The move continues a pattern of FDA shifting next-generation sequencing diagnostics from case-by-case PMA review toward a standardized 510(k) pathway.