Frequently Asked Questions
Can I market my device after submitting the 513(g)?
The 513(g) submission helps to clarify the classification and regulatory requirements for your medical device, but it does not grant you approval to market your device. The FDA will determine your regulatory pathway with their 513(g) ruling.
What are the pathways for De Novo submission?
There are two De Novo process pathways that can assist in obtaining a reclassification of your novel device.
- The first option is the pre de novo submission (PDS). The PDS involves early-stage discussions with FDA reviewers to determine whether your device is a good de novo candidate, as well as which materials you should provide to the FDA as part of your de novo petition.
- The second option is a standard 510(k) submission resulting in a not substantially equivalent (NSE) decision by FDA reviewers. Following the NSE, you have 30 days to submit a de novo petition.
What happens once a de novo is granted?
After a de novo is granted by the FDA, the specific device and device type is classified as Class I or Class II. The device may then be marketed immediately and serve as a predicate device.
Can I file a De Novo and a 510(k) at the same time?
No. Upon receipt of a De Novo submission, the FDA will search their database to see if any submission for your product is in process. If they find that you have submitted your device for review,
Should we submit a “Pre Sub” before submitting a De Novo?
Yes, the FDA strongly recommends filing a “Pre Submission” if no products similar to yours have been reviewed via the 510(k) process.