2026-20443·DEPARTMENT OF HEALTH AND HUMAN SERVICES

Medical Devices; Immunology and Microbiology Devices; Classification of the High Throughput DNA Sequencing for Hereditary Cancer Predisposition Assessment Test System

Final RuleEffective

Published: Oct 6, 2026
Effective: Oct 6, 2026
Citation: 91 FR 63487
Docket: Docket No. FDA-2026-N-10990
Agencies: DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration

Final amendment; final order.

Summary

The Food and Drug Administration (FDA) has re‑classified high‑throughput DNA‑sequencing systems used to assess hereditary cancer risk as a Class II medical device. Class II devices are subject to “special controls”—specific performance standards and labeling requirements—that the FDA believes will ensure the tests are safe and effective while still allowing quicker market entry for innovative technologies. The move is intended to balance patient safety with easier access to advanced genetic testing tools. This final rule is issued by the U.S. Department of Health and Human Services, through the FDA, and applies to manufacturers of these sequencing test systems, as well as laboratories that use them to evaluate patients for hereditary cancer predisposition. By placing the devices in Class II, the FDA will enforce the identified special controls rather than the more burdensome pre‑market approval process required for higher‑risk (Class III) devices. The regulation was published in the Federal Register on October 6, 2026 (91 FR 63487) and is effective immediately on that same date. With the rule now final, manufacturers must comply with the specified special controls for any new or existing products. The FDA will monitor compliance and may issue guidance or updates as the technology evolves, but no additional public comment period is required because the rule is already finalized.

AI-generated summary — verify against the Federal Register text.

Official abstract

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.