FDA Ends Device Approval Requirement for Colon Capsule Imaging Systems

The Food and Drug Administration announced the reclassification of colon capsule imaging systems as Class II medical devices subject to special controls. Colon capsule imaging systems were previously classified in Class III and required premarket approval. The reclassification took effect Jan. 29; FDA’s final order merely codifies it into regulation. Although they will no longer need FDA approval, the devices will still be subject to premarket notification requirements, as well as certain extra "special controls" related to testing, biocompatibility, and labeling.