Did you know that FDA is willing to fill in some voids?

Do you have questions about your laboratory testing to show substantial equivalence to a predicate device?

How about animal testing – are you unsure of the animal model to demonstrate performance for your implantable product that is regulated in the 510(k) pathway?

Or, clinical – are you uncertain about how much clinical data will be required to support a new software diagnostic device?

These are the types of questions FDA’s Center for Devices (CDRH) will answer in the pre-submission process.  It is called a “Q-Sub”.  Why is that?  FDA assigns a “Q” number to the new submission for tracking purposes.

This is one of the most valuable interactive processes CDRH has developed and it works extremely well.  

What is involved?
(1) You develop the Q-Sub based on the FDA’s finalized (2017) guidance document
(2) Is there a form to complete?:
No, but Qserve uses templates we have developed to start the process with a client.
(3) A Q-Sub can have one of many purposes, for example:
a. For pre-IDE
b. For pre-510(k)
c. For pre-De Novo
(4) Depending on the purpose, the contents will vary.
(5) But generally, it requires developing a summary of your technology, a summary of testing completed and testing planned, and a list of questions that FDA will address in the feedback.
(6) Can your question be a general “please tell me what to do”?
No, you have to present directed questions to guide FDA’s review of your issues.
(7) FDA’s feedback is received within 75-90 days after acceptance of the Q-Sub.
(8) How is that feedback provided:
a. Always in writing
b. Also via conference call or face-to-face meeting, if requested and warranted.
(9) What if you have post-Q-Sub feedback questions?  Does CDRH close the door?  No:  You can submit a supplement if follow-on questions are related to the topic and the first round of feedback

Should you have any questions about this, then do not hesitate to contact us. We are happy to discuss! 


We offer a wide range of training program, check our events calender or follow us on LinkedIn and subscribe to our (monthly) newsletter to stay up-to-date on the latest regulatory and clinical news in the medical devices area.


Patsy Trisler
Post date: June 27, 2018
How can we help you? Contact us