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What are some common reasons as to why a 510(k) submission would not be accepted?

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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.

First, it is important to determine whether or not the device type is eligible for a 510(k) submission. The FDA will determine whether the device is eligible for a 510(k) submission, or if it is an inappropriate regulatory approach (i.e. Class III PMA, Class I or II exempt). This will occur during the acceptance review process and the submitter will be notified of the determination.

Another potential reason is if the submitter has a PMA for the same device with the same indications for use pending. In this scenario, the review team will stop the review clock. The 510(k) review team will consult with other management to determine which premarket review pathway applies to the device and how the situation should be addressed.

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