Keyword Analysis & Research: 510k vs de novo

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Frequently Asked Questions

What is the difference between de novo and 510(k)?

Between De Novo and 510 (k), in many ways, the De Novo pathway is the simpler option. When companies undergo a 510 (k) submission, they must prove both substantial equivalence and a solid risk mitigation strategy to FDA.

When to use the 510(k) ède novo pathway?

Pathway #1: 510(k) ède novo ØWhen to use: You believe you have a suitable predicate device. 1. Sponsor submits 510(k) submission – this should be a complete 510(k) submission 21 Submission Process: Pathway #1: 510(k) ède novo 2. FDA reviews 510(k) submission; makes NSE finding due to lack of predicate

What is the subsubmission process for the 510(k)?

Submission Process: Two Pathways Pathway #1: 510(k) ède novo • attempt 510(k) route with proposed predicate device • submission found NSE, but candidate for de novo Pathway #2: direct de novo • useful if you believe proposed device is viable de novo candidate (esp. with feedback from Pre-Sub program) 20 Submission Process:

What is a de novo submission to FDA?

In order to legally market a device in the US, the most common forms of premarket submissions to FDA are the 510 (k) premarket notification submission and the PMA premarket approval. Another lesser known premarket submission is the de novo submission. Each of these submission types result in a determination by FDA that clears [510 (k)], ...

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