FDA Pre-Submissions: 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.

RQMIS Saves Time and Money Using Pre-Submission

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.

The situation: Novel Device Technology (electro medical device with software) – submit a 510k or a De Novo (new device)?

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 device and initial informal feedback from FDA indicated the De Novo process was indicated. Since the consequences to the client in time and money associated with the De Novo process were severe, the client asked RQMIS for guidance.

RQMIS:

  • Identified the problem
  • Filed a pre-submission with the FDA
  • Arranged for the entire client team to teleconference with the FDA
  • Negotiated with the FDA on the client’s behalf

The pre-submission requested that the FDA consider a 510k submission (rather than a De Novo) supported by additional device verification testing to show that although the device had a novel technology, the device was as safe and effective as the other devices in the market with closely related technology.

During the teleconference and negotiations with the FDA, it was concluded that a 510k submission with additional testing was suitable for the new device under assessment. The De Novo process was unnecessary.

RQMIS saved the client time, money and resources.

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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