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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

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.

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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