Differences between 510(k) and De Novo Submission

Differences between 510(k) and De Novo Submission

Traditionally, Class II medical devices would have 2 routes for FDA submission:

  1. 510(k), which would require a substantial equivalence (SE) analysis based on previously FDA cleared device. Substantial equivalence requires the device is as safe and effective as the predicate device. Additionally, it requires the same intended use and technological characteristics as the predicate device. In today’s world of novel and innovative medical technology, meeting these requirements is increasingly difficult.
  2. In the event substantial equivalence cannot be proven, the device is to automatically be classified as class III and require a PMA (Pre-Market Approval) submission. As such, the PMA submission process is quite rigorous, especially for a class II, medium risk device.

In light of this situation, over the last few years, the FDA has created a De Novo submission program, which allows for novel technologies (i.e.: lacking SE) to be classified as a class II device, with a submission not quite as rigorous as the PMA submission.

The De Novo submission process is similar in complexity to the 510(k) submission, but there are a number of differences:

  1. Clinical Investigations – while clinical trials are sometimes not required for 510 (k) submissions (when based on previous clinical results for SE devices), clinical trials are required for virtually all De Novo submissions.
  2. Risk Factor – For a De Novo submission, the manufacturer must prove that the risk factor presented with this device is a medium risk (i.e.: not present substantial risk to the patient). As for 510(k) submission, the manufacturer must merely prove that the risk presented by the device is no greater than its SE device.
  3. Submission cost – For the year 2018, the submission fees for the FDA are as follows:
Submission Type Standard Fee Small Business Fee
510(k) $10,566 $2,642
De Novo $93,229 $23,307

If you need assistance making a determination regarding the submission requirements of your device or navigating the difference submission processes, please contact us (link to contact section) today via phone or email for a free consultation.