Business · 17/06/2026Updated: 10/17/2026 · 1 min read
FDA Classifies Ingestible Gastrointestinal Blood Detection Capsule into Class II with Special Controls
Summary
The FDA has classified the ingestible gastrointestinal blood detection capsule into Class II, a designation that will provide a reasonable assurance of safety and effectiveness, while also reducing regulatory burdens and enhancing patients' access to innovative devices.
Original source language: Federal Register — Health and Human ServicesOpen original release →