Why is the FDA Pre-submission tool underused?


Food and Drug Administration is a government entity in the United States whose objective is to protect the public by verifying that nutritional supplements are safe to use and accurately labelled. Businesses can even use the FDA Pre-submission to get feedback on possible and planned medical advice, biologics and medication submission. It’s a fantastic service to use, but we have noticed that it’s often overlooked.

Brief about FDA Pre-submission:

You can use the pre-submission to get formal comments on your medical product before submitting 510k Application. This is referred to as a Q-submission. It came out of a need to provide expanded access to the FDA and allows the company to get valuable comments ahead of time. This action will put your company on track to get your device to market faster. It will also give you a red signal beforehand to deal with the issues ahead of time. The FDA Pre-submission program continues to grow now, including various medical devices submission from which a company can pick when bringing a device to market. the list of submission is known as Q-submission which include:

  • Duel
  • HDE- (Humanitarian device exemption)
  • Premarket notification etc

Pros of Pre-submission:

  • Will using FDA Pre-submission be useful for the company? This is one of the most asked questions when it comes to pre-submission.
  • With the FDA, you create a “human” relationship. They are, after all, human beings who are curious about who you are.
  • You may remove all the risks from your application beforehand. You are asked questions concerning the things you may know and things you don’t know.
  • You can obtain “free guidance” to assist you in the development and regulatory plan.
  • It may request a review of your pre-submission documents by providing you with “bonus points”.

Cons of Pre-submission:

  • There always the issue of money and time.
  • You had to pay $5000-$25000 only to consult with a pre-submission.
  • The normal process goes up to 60-75days.
  • The most asked query is that “What is they will say no to our work and instead demands to do X, Y, Z?
  • Is our response that isn’t preferable enough to know about this matter before submitting? So, the main issue is the picked up by FDA, so it’s a lot better use of your time to have discovered it during pre-submission.
  • Perhaps these drawbacks are a key reason why the pre-submission is underutilized, but I strongly advise you not to discourage you from using it.


The FDA Pre-submission programme is a useful tool that is often overlooked. It makes good financial sense in most cases. You have the chance to introduce yourself to the FDA and to learn feedbacks on issues concerning your application.