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

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About the Author
Proxima CRO Team
Isabella Schmitt, RAC
Director of Regulatory Affairs
Ms. Schmitt has also served in additional regulatory affairs and clinical research roles in which she contributed to multiple regulatory submissions and clinical affairs projects across a wide range of indications.

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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