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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
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 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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