In the US, medical device and IVD manufacturers whose products pose no significant risks but have no identifiable predicate devices are usually classified as Class III by the Food and Drug Administration (FDA).
The FDA De Novo process is designed for “novel” medical devices and IVDs for which manufacturers cannot establish substantial equivalence, but whose risk profiles do not necessarily warrant Class III designation. If you believe your device qualifies for the FDA De Novo process, Emergo has the regulatory and technical expertise to fully support you.
There are two De Novo process pathways Emergo can help you navigate in order to obtain a reclassification of your novel device. The first option is the pre De Novo submission (PDS), which involves early-stage discussions with FDA reviewers to see 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.
USFDA De Novo submission steps:
- Review and Assessment: We will review your device information and provide our own De Novo assessment prior to contacting the FDA
- Pre-De Novo or De Novo Determination: We will use guidance documents to make an informed De Novo determination
- De Novo Application: We will write and compile your De Novo application and submit it to the FDA
- Post-submission Support: Following submission, we will provide support and deal with any FDA feedback