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:

Q submission Program includes:

Other interactions that are tracked under Q submission:

Submission Process:

Content (In English):

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  1. Q-sub Cover Letter
  2. Purpose
  3. Device or Product Description
  4. Proposed Indication for Use or Intended Use
  5. Regulatory History

How to submit:

  1. eCopy of your Q-Sub 
  2. Q-Sub should be mailed to the CDRH Document Control Center (DCC) or the CBER DCC.

FDA Submission Tracking FDA assigns a unique identification number to all types of Q-Subs:

Timeline & Method of Feedback of Q-Sub:

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