# Federal Register rule 2026-07863

> The Federal Register published rule 2026-07863, attributed to FDA and its parent HHS department, on 2026-04-22. Its official title is “Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Setmelanotide Eligibility Gene Variant Detection System,” and PeptideScanner's exact reviewed identity mapping connects the document to Setmelanotide.

- Evidence object: `story:federal-register-2026-07863:v1`
- Evidence domain: Regulatory
- Date in source: 2026-04-22
- Source checked: 2026-08-21
- Published by PeptideScanner: 2026-08-21
- Story landing page: https://peptidescanner.com/stories/federal-register-2026-07863/
- JSON record: https://peptidescanner.com/evidence/v1/objects/federal-register-2026-07863-v1.json
- Content SHA-256: `40d8715f3a57f903034cd1a3b1fb9abe706c759ff8eeb2174889aa7fd3e23446`

## Claims and source pins

### Headline

Federal Register rule 2026-07863 ([`federal-register-2026-07863-35bd6782c101`](#source-federal-register-2026-07863-35bd6782c101))

### Summary

The Federal Register published rule 2026-07863, attributed to FDA and its parent HHS department, on 2026-04-22. Its official title is “Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Setmelanotide Eligibility Gene Variant Detection System,” and PeptideScanner's exact reviewed identity mapping connects the document to Setmelanotide. ([`federal-register-2026-07863-35bd6782c101`](#source-federal-register-2026-07863-35bd6782c101))

### Paragraph 1

The Federal Register published rule 2026-07863, attributed to FDA and its parent HHS department, on 2026-04-22. Its official title is “Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Setmelanotide Eligibility Gene Variant Detection System,” and PeptideScanner's exact reviewed identity mapping connects the document to Setmelanotide. ([`federal-register-2026-07863-35bd6782c101`](#source-federal-register-2026-07863-35bd6782c101))

### Paragraph 2

This page reports bounded metadata from a Federal Register document attributed to FDA and its parent HHS department, and links to the official GovInfo PDF. It does not interpret legal effect, approval, safety, effectiveness, compounding status, or medical use. ([`federal-register-2026-07863-35bd6782c101`](#source-federal-register-2026-07863-35bd6782c101))

## Sources

<a id="source-federal-register-2026-07863-35bd6782c101"></a>
- **Federal Register rule 2026-07863 · published 2026-04-22 · Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Setmelanotide Eligibility Gene Variant Detection System** — Federal Register via GovInfo; class A. [Open source](https://www.govinfo.gov/content/pkg/FR-2026-04-22/pdf/2026-07863.pdf) (`federal-register-2026-07863-35bd6782c101`)

## Correction lineage

No correction is recorded for this version.

## Reporting boundaries and unknowns

PeptideScanner reports the cited regulator or label record. It does not extend that record into broader safety, effectiveness, or approval claims.

- Sources outside the selected public PeptideScanner bundle may exist and are not represented by this object.
- This object does not determine whether cited records agree, corroborate one another, or establish scientific truth.
- This object does not determine safety, efficacy, causality, or suitability for any person.

Methodology: https://peptidescanner.com/methodology/
Medical disclaimer: https://peptidescanner.com/medical-disclaimer/

## Suggested citation

PeptideScanner. "Federal Register rule 2026-07863." Version 1, published 2026-08-21. https://peptidescanner.com/evidence/v1/objects/federal-register-2026-07863-v1.json SHA-256: 40d8715f3a57f903034cd1a3b1fb9abe706c759ff8eeb2174889aa7fd3e23446.

