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FDA Q-submission

FDA Q-submission

A structured process for managing and tracking interactions between manufacturers and FDA about future applications for approval or clearance, prior to the following submissions: 

Investigational Device Exemption (I DE)
Premarket Approval (PMA)
Humanitarian Device Exemption (HDE)
Premarket Notification(510(k))
De Novo Request
Clinical Laboratory Improvement Amendments (CLIA) Waiver by Applications (CW)
Dual 510(K)
Certain Investigational New Drug Applications (INDs)
Biologics License Applications (BLAs)

Q submission Program includes

Other interactions that are tracked under Q submission

Submission Process

Content (In English): OMC Medical – omcmedical.com

How to submit?

Timeline & Method of Feedback of Q-Sub

OMC Medical can assist you with the Q Submission process and contact us at [email protected]