Medical Devices; Gastroenterology-Urology Devices; Classification of the Ingestible Gastrointestinal Blood Detection Capsule
Built by the Tribune's code from the Federal Register. No AI wrote this page. Published in the Federal Register June 17, 2026. Document 2026-12165. Updated Nov. 9, 2026.
- What it does
The Food and Drug Administration (FDA) is classifying the ingestible gastrointestinal blood detection capsule 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 ingestible gastrointestinal blood detection capsule. 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.
The Food and Drug Administration's summary, as published in the Federal Register.
- What changed in the regulation
1 part of Title 21 of the Code of Federal Regulations:
Wording on eCFR: the day before it took effect and from the day it took effect (first part listed).
- Compared with
The Food and Drug Administration has published 100 final rules in 2026 so far, compared with 68 in all of 2025.
Counted by the Tribune from Federal Register records since Jan. 1, 2025.
- What happens next and when
This order is effective June 17, 2026. The classification was applicable on February 24, 2023.
The agency's dates, word for word.
The record as published
| Document number | 2026-12165 |
|---|---|
| Action | Final amendment; final order. |
| Agencies | Health and Human Services Department; Food and Drug Administration |
| Published | June 17, 2026 |
| Effective date | June 17, 2026 |
| Docket | FDA-2026-N-6536 |
Source: the Federal Register (public domain). The document in the Federal Register