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What happens if there is a pending 510(k) or PMA application for the same device with the same indications for use?
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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 De Novo requester has a pending 510(k) or PMA for the same device with the same indications for use, the De Novo review team should place the De Novo request on administrative hold and work with the De Novo requester to clarify the appropriate regulatory pathway and premarket submission type. The review team should also consult management and other Center resources to determine which premarket review pathway applies to the device and the appropriate processes for addressing the situation. FDA staff should also consult management and other Center resources if a 510(k) or PMA has been submitted for the same device type by different applicants.

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