FDA codifies six device classifications with specific special controls

What happened

FDA published three codification orders October 6 for hereditary-cancer sequencing, adjunct hyperoxia monitoring, and nonthermal mechanical ultrasound ablation, and three October 9 for home-collected nonviral STI specimens, over-the-counter infant pulse/oxygen monitoring, and hematopoietic cell enrichment. The orders take effect on their October publication dates, while each classification was applicable on its stated 2023 De Novo date. They establish Class II categories and special controls; they do not newly classify every related technology on the same October date or authorize every possible clinical indication.

The controls preserve different clinical boundaries. Hereditary-cancer sequencing is prescription testing that aids predisposition assessment, not screening, prenatal testing, or standalone diagnosis. Hyperoxia monitoring is adjunctive and warns against relying on output without arterial-blood-gas confirmation. Mechanical ultrasound ablation requires injury, monitoring, and failure safeguards and labeling that no specific disease treatment was evaluated. Home STI specimens are collected by lay users but tested in clinical laboratories with validated collection, transport, and instructions. Infant monitors require performance across confounders, validation of any alarms, and caregiver comprehension. Cell-enrichment kits support later diagnostic assays, require end-user validation, and do not themselves diagnose or enumerate cells. Those category-specific uses and evidence controls remain central to implementation.

Why it matters

All six are Class II classifications with special controls, reflecting 2023 classification applicability. This publication is not a blanket new product authorization or an exemption from every premarket duty.

Sources

• Medical Devices; Immunology and Microbiology Devices; Classification of the High Throughput DNA Sequencing for Hereditary Cancer Predisposition Assessment Test SystemOfficial · HHS · 2026-10-06 · Source review 2026-10-11
• Medical Devices; Cardiovascular Devices; Classification of the Hyperoxia Monitoring Device Adjunct to Pulse OximetryOfficial · HHS · 2026-10-06 · Source review 2026-10-11
• Medical Devices; General and Plastic Surgery Devices; Classification of the Focused Ultrasound System for Non-Thermal, Mechanical Tissue AblationOfficial · HHS · 2026-10-06 · Source review 2026-10-11
• Medical Devices; Immunology and Microbiology Devices; Classification of the System for Detection of Nucleic Acid From Non-Viral Microorganism(s) Causing Sexually Transmitted Infections Using Home-Collected SpecimensOfficial · HHS · 2026-10-09 · Source review 2026-10-11
• Medical Devices; Cardiovascular Devices; Classification of the Infant Pulse Rate and Oxygen Saturation Monitor for Over-the-Counter UseOfficial · HHS · 2026-10-09 · Source review 2026-10-11
• Medical Devices; Immunology and Microbiology Devices; Classification of the Hematopoietic Cell Enrichment KitOfficial · HHS · 2026-10-09 · Source review 2026-10-11