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510(k) Pre-Submission or Q-Submission

A Pre-Submission is a formal written request seeking the FDA’s feedback before an application is submitted for review.  It allows the submitter to request formal feedback on the files of his medical device specifically on (a) test protocols (b) substantial equivalence (c) missing section etc. before he makes an FDA review payment and submit a 510(k) application.

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Benefits of Pre FDA 510(k) Submission

  • Allows you to obtain feedback from the FDA on your plan so that you don’t waste a lot of time and money by going down the wrong path

  • Improved quality of final 510(k) file

  • Reduces the chance of any surprises coming up after your application is submitted to the FDA

  • Enhanced transparency of the review process

  • Smooth and clear review comments

  • Potentially shorter total review times

  • Clarity regarding each aspect of submission

  • Detailed understanding for appropriate 510(k) submission

  • Helps determine an efficient path from device concept to approval

  • No fee

 

In Q-Submission electronic copy (eCopy) of the technical file is submitted to CDRH Document Control Center (DCC).  In eCopy submission the documents shall be stored in a compact disc (CD), digital video disc (DVD) or flash drive. eCopy Validation Module should be used to ensure your eCopy is formatted correctly.  A paper copy of the cover letter in companies letter head (including a signature) shall be attached to the eCopy (CD, DVD or flash drive).

 

FDA staff will conduct an acceptance review using the Acceptance Checklist within 15 days after the 510(k) submission. The submitter will receive notification regarding whether the submission has been accepted for review.

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If FDA determines that the information provided is insufficient, the request will be refused to accept or RTA and the sponsor should provide the additional information which will be logged in as an amendment to the Q-Submission.

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