Opportunity
Federal Register #2026-12165
FDA Classification of Ingestible Gastrointestinal Blood Detection Capsule as Class II Medical Device
Buyer
Department of Health and Human Services / Food and Drug Administration
Posted
June 17, 2026
Identifier
2026-12165
This FDA final order establishes the regulatory classification for an ingestible gastrointestinal blood detection capsule: - Government buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - OEMs and vendors: - EnteraSense Ltd. (OEM of the Pill Sense System) - Products/services requested: - No procurement or solicitation; the notice classifies the device as a class II medical device - Device uses spectrophotometry to detect blood in the gastrointestinal tract - Unique or notable requirements: - Special controls for safety and effectiveness, including: - Clinical and non-clinical performance testing - Biocompatibility evaluation - Software validation - Electrical and mechanical safety - Usability assessment - Shelf life testing - Specific labeling for physicians and patients - Device is for prescription use only - Purpose: - Classification action aims to reduce regulatory burdens and improve patient access to innovative devices - No procurement or solicitation for products or services is included in this notice
Description
The Food and Drug Administration (FDA) is classifying the ingestible gastrointestinal blood detection capsule into class II (special controls). This device is a prescription device that uses spectrophotometry to detect the presence or absence of blood in the gastrointestinal tract. The classification aims to provide reasonable assurance of safety and effectiveness, reduce regulatory burdens, and improve patient access to innovative devices. The classification became effective on June 17, 2026, with the classification applicable since February 24, 2023.