Ingestible Telemetric Gastrointestinal Capsule Imaging System - Final Class II Special Controls Guidance Document for Industry and FDA

Ingestible Telemetric Gastrointestinal Capsule Imaging System - Final Class II Special Controls Guidance Document for Industry and FDA


Publication/Creation Date
November 28 2001
Creators/Contributors
Food And Drug Administration (FDA) (creator)
Persuasive Intent
Information
Description
This is a guidance document detailing the Class II special controls that producers of generic ingestible telemetric gastrointestinal capsule imaging system devices must follow. This is after the FDA approved a move for the devices to go from a Class III to a Class II designation in August 2001. It lays out the risks to health, scope, etc. that industry producers of the capsule and the FDA need to consider before marketing versions of the device to the public.
HCI Platform
Ingestible
Location on Body
Digestive Tract
Marketing Keywords
Source
https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/ingestible-telemetric-gastrointestinal-capsule-imaging-system-final-class-ii-special-controls

Date archived
May 14 2020
Last edited
November 5 2020
How to cite this entry
Food and Drug Administration (FDA). (November 28 2001). "Ingestible Telemetric Gastrointestinal Capsule Imaging System - Final Class II Special Controls Guidance Document for Industry and FDA". Food and Drug Administration (FDA). Center For Devices And Radiological Health. Fabric of Digital Life. https://fabricofdigitallife.com/Detail/objects/4549