Ingestible Telemetric Gastrointestinal Capsule Imaging System - Final Class II Special Controls Guidance Document for Industry and FDA
Publication Title
Food and Drug Administration (FDA)Publication/Creation Date
November 28 2001Creators/Contributors
Food And Drug Administration (FDA) (creator)Media Type
Government PublicationPersuasive Intent
InformationDescription
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
IngestibleDiscursive Type
Responses To InventionsLocation on Body
Digestive TractTechnology Keywords
Ingestible Capsules, Imaging System, Telemetry, Radiology, Wireless Connectivity, Medical DeviceSource
https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/ingestible-telemetric-gastrointestinal-capsule-imaging-system-final-class-ii-special-controlsRelated Objects
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