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Requests for Feedback and Meetings for Medical Device Submis
Requests for Feedback and Meetings for Medical Device Submis
Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program
This guidance describes the mechanisms available through which submitters can request FDA feedback regarding potential or planned medical device submissions.
Related Keywords
,
Drug Administration ,
Public Health Service ,
Guidance Issuing Office ,
Clinical Laboratory Improvement Amendments ,
Radiological Health ,
Docket Number ,
Biologics Evaluation ,
Investigational Device Exemption ,
Premarket Approval ,
Humanitarian Device Exemption ,
Automatic Class ,
Premarket Notification ,
Application Submissions ,
Accessory Classification Requests ,
Investigational New Drug Applications ,
Biologics License Applications ,