FDA De Novo Pre-Submission Guidance

Defining Regulatory Pathway and Developing Verification and Validation Test Requirements

The Situation

An international client wants to introduce a medical device with an innovative technology to the U.S. market. The device has no predicate; so, do you submit a 510k or a De Novo (new device)?

The Solution

A DeNovo submission is costly and time consuming, because it requires extensive safety and efficacy testing. RQMIS Identified the problem, filed a pre-submission with the FDA, arranged for the entire client team to teleconference with the FDA, and negotiated with the FDA on the client’s behalf.

Discussions with the FDA concluded that a 510k submission with additional testing was suitable for the new device under assessment. This saved the manufacturer significant time and money.

Getting a medical device to the market is not always straightforward and simple. Often a medical device has no predicate device or needs a clinical study to obtain clearance. Situations such as these are candidates for the FDA pre-submission program.

What is a pre-submission?

Pre-submission allows device manufacturers to request feedback from the FDA regarding planned or potential medical device submissions. A typical pre-submission involves building a document illustrating the device, proposed testing and the proposed regulatory strategy to the FDA.

How long does it take, and is there a fee?

It takes approximately 60-70 days to receive a written FDA response to a pre-submission. There are no fees to submit.

What is the advantage of a pre-submission over a traditional submission?

If you are unsure of your regulatory strategy, pursuing a novel regulatory pathway, what to reach consensus with FDA on preclinical and clinical study requirements, a pre-submission will get you written feedback on your proposed regulatory path and requirements for testing, as well as a teleconference and informational meetings with the FDA, which may lead to a quicker approval when you do submit traditionally.

Q: Traditional 510(k) submission or De Novo 510(k)?

An international client wanted to introduce a medical device with an innovative technology to the US market. The novelty of the device meant that it had no predicate devices to compare to, and initial informal feedback from the FDA indicated a De Novo submission as the correct path forward. If the client were to follow the De Novo process it would cost them significant time and money, expenses they were not prepared to endure. This is why they came to RQMIS for guidance.

How did RQMIS handle this situation? Our experience consultants did the following:

  • Identified the problem
  • Filed a Pre-submission with the FDA
  • Arranged for the entire client team to teleconference with the FDA to ensure everyone was on the same page
  • Negotiated with the FDA on the client’s behalf

The Pre-submission we submitted requested that the FDA consider the possibility of client using a Traditional 510(k) submission instead of a De Novo, and supported this with additional device verification testing. This demonstrated that although the product had a novel technology, the device itself was as safe and effective as the other devices currently on the market with closely related technology.

The outcome: During the teleconference and negotiations with the FDA it was concluded that a Traditional 510(k) submission with additional testing would be suitable for the client's medical device, and that the De Novo process was actually not needed. RQMIS was able to save the client time, money, resources, and an unnecessary headache!

Do you have a novel or otherwise complicated product you want to bring to market?

Need advice?

Contact RQMIS at info@rqmis.com, call us at (978) 358-7307, or just click the Contact button below.


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