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About the Author
Proxima CRO Team
Isabella Schmitt, RAC
Director of Regulatory Affairs

Prior to joining Proxima, Isabella served as the Senior Regulatory & Quality Manager at a medical device company, where she outlined the regulatory strategy & put together design controls & design history documentation. She was the Dir. of CMC & Quality at a biopharmaceutical company, where she oversaw all manufacturing and analytical processes and timelines and ensured CMC regulatory strategy was sufficient for filings in Europe and the US.

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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