Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the
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 setme
| Agency | Health and Human Services Department, Food and Drug Administration |
|---|---|
| Document type | Rule |
| Published | 2026-04-22 |
| Summary | 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. |
| Document number | 2026-07863 |
| Official record | https://www.federalregister.gov/documents/2026/04/22/2026-07863/medical-devices-clinical-chemistry-and-clinical-toxicology-devices-classification-of-the |