FDA 483 - Cochlear Americas Inc. - October 21, 2021
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
An FDA inspection of Cochlear Americas Inc. in Lone Tree, CO, revealed a significant issue regarding a non-significant risk device study. The firm failed to meet abbreviated requirements for investigational device exemptions (IDEs), specifically concerning the informed consent process. The informed consent used by an investigational site included assigned likelihoods for risks not found in the sponsor's labeling and additional study procedures not defined in the Clinical Investigational Plan, without documented sponsor review and approval.
- Office
- Denver District Office
- Person
ID · 097e786d-e3b6-40a3-b4ff-93e96aba01a8