What happens if you submit your device for a 510(k) clearance, and it gets denied?


If the FDA determines that the device is NSE due to lack of a predicate, new intended use, or different technology issues at the end of the 510(k) review, the device may be eligible for a De Novo. 510(k) reviewal will follow standard practices, and the NSE letter may indicate that a De Novo classification may be appropriate. The De Novo should be submitted within 30 days.

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About the Author
Proxima CRO Team
Dora Huang

Dora Huang is from Houston, TX and is a jack-of-all-trades. Dora is a Regulatory Affairs and Graphics Design Intern for Proxima. She has experience working on projects that vary from engineering water systems to tissue engineering.

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