# Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Setmelanotide Eligibility Gene Variant Detection System
> **Food and Drug Administration** · Final amendment; final order. · Published 2026-04-22 · Effective 2026-04-22 · 91 FR 21376
## Document
- **Document number:** 2026-07863
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 91 FR 21376
- **CFR reference:** 21 CFR 862
- **Publication date:** 2026-04-22
- **Effective date:** 2026-04-22
- **HHS docket:** Docket No. FDA-2026-N-3900
## Abstract

The Food and Drug Administration (FDA, the Agency, or we) is classifying the setmelanotide eligibility gene variant detection 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 setmelanotide eligibility gene variant detection system. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of 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.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2026/04/22/2026-07863/medical-devices-clinical-chemistry-and-clinical-toxicology-devices-classification-of-the)
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