Videos

The Q Submission Program

MedTech
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Compliance & Regulatory: MedTech
Are you a new medical device seeking FDA market approval? If so, there's a good chance you'll need to be familiar with the FDA's Q-Submission Program!

Are you a new medical device seeking FDA market approval?

If so, there's a good chance you'll need to be familiar with the FDA's Q-Submission Program!

In this quick video, watch our Regulatory Affairs team member, Grace Carrell, MBA, MMB, review:

  • What are Q-submissions?
  • What takes place in FDA Q-submission interactions & what benefit they can bring to your medical device.
  • Do you know the different types of Q-submissions, feedback methods, and timelines for each?
  • And most importantly, the 3 main benefits of the Q-Submission Program!

Learn more about the format of a Q-submission meeting, here