# Federal Register #2026-20443

FDA classifies hereditary cancer DNA sequencing systems as Class II medical devices

**Buyer:** Food and Drug Administration
**Posted:** October 06, 2026
**Identifier:** 2026-20443

The U.S. Food and Drug Administration issued a final regulatory order for hereditary cancer DNA sequencing test systems.
- **Government agency:** U.S. Department of Health and Human Services (HHS), Food and Drug Administration (FDA).
- **Regulatory action:** High-throughput DNA sequencing test systems used to assess hereditary cancer predisposition are classified as Class II medical devices.
- **Requirements:** The devices are for prescription use, subject to device-specific special controls, and remain subject to 510(k) premarket notification requirements.
- **Procurement status:** This is a regulatory action, not a solicitation or award. No OEMs, vendors, purchase quantities, part numbers, or requested products or services are identified.

### Description

The FDA is classifying the high throughput DNA sequencing for hereditary cancer predisposition assessment test system as a class II device subject to special controls. The order identifies the special controls that will be included in the codified classification requirements. FDA states that class II classification provides reasonable assurance of safety and effectiveness and may improve access to innovative devices by reducing regulatory burdens. The device is subject to premarket notification requirements under section 510(k) of the FD&C Act.

[View original listing](https://www.federalregister.gov/documents/2026/10/06/2026-20443/medical-devices-immunology-and-microbiology-devices-classification-of-the-high-throughput-dna)