# 2026-12165: Swallowable Blood Detector Gets Class II Status

2026-12165, Medical Devices; Gastroenterology-Urology Devices; Classification of the Ingestible Gastrointestinal Blood Detection Capsule, is a Federal Register rule from Health and Human Services Department, Food and Drug Administration published 2026-06-17, effective 2026-06-17; PRIA reads it as touching household money (as of 2026-06-24).

- Canonical: https://policyrisk.com/federal-register/2026-12165
- As of: 2026-06-24
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2026-12165
- Title: Medical Devices; Gastroenterology-Urology Devices; Classification of the Ingestible Gastrointestinal Blood Detection Capsule
- Type: Rule
- Agencies: Health and Human Services Department; Food and Drug Administration
- Citation: 91 FR 36520
- Published: 2026-06-17
- Effective: 2026-06-17
- Comments close: not stated
- Significant: no
- Touches household money: yes
- Regulation identifier numbers: none
- Last updated: 2026-06-24

## In one line

Swallowable Blood Detector Gets Class II Status

## Summary

The FDA is officially putting the ingestible gastrointestinal blood detection capsule into Class II, meaning it now has special safety rules but fewer hurdles than before. This change helps patients get access to this cool, innovative device faster and keeps it safe and effective. The new classification is effective June 17, 2026, and could save time and money for makers and users alike.

## Abstract

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.

## Effects PRIA read

- Easier pathway for future device makers: benefit, medium. If you make medical devices, FDA’s De Novo classification of the ingestible gastrointestinal blood detection capsule means this device can serve as a predicate for future devices, allowing sponsors to use the less-burdensome 510(k) process instead of a De Novo or premarket approval pathway. This ch…
- New safety and labeling requirements: benefit, medium. The device is now Class II with specific special controls that require clinical performance testing (including comparison to endoscopy for detecting GI bleeding, capsule excretion/recovery, and all adverse events), many non-clinical tests (dimensional, performance, battery life, leak, bite, pH resi…
- Premarket 510(k) submission required: cost, medium. Manufacturers of ingestible gastrointestinal blood detection capsules must submit a premarket notification under section 510(k); FDA has not exempted this device type under section 510(m). This premarket notification requirement applies as part of the Class II classification effective June 17, 2026…

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## Sources
- [2026-12165 on federalregister.gov](https://www.federalregister.gov/documents/2026/06/17/2026-12165/medical-devices-gastroenterology-urology-devices-classification-of-the-ingestible-gastrointestinal)
- [2026-12165 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2026-06-17/pdf/2026-12165.pdf)

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Source: PRIA, https://policyrisk.com/federal-register/2026-12165 (as of 2026-06-24).