Which is a common reason for the rejection of a 510(k) submission by the FDA?

A common reason for the rejection of a 510(k) submission by the FDA is insufficient evidence of substantial equivalence. The 510(k) process allows manufacturers to demonstrate that their device is as safe and effective as a legally marketed device (the predicate) by providing sufficient clinical and non-clinical data. If the submitted data does not adequately prove that the new device is substantially equivalent in terms of safety and effectiveness to the predicate device, the FDA will likely reject the submission. This requirement is fundamental to ensuring that new devices meet the necessary regulatory standards before they can be marketed.

While improper labeling of the device can also lead to issues, it typically falls under a different category of regulatory non-compliance and may not directly lead to rejection of the submission itself if the core substantive data is sound. High manufacturing costs and lack of market research, while potentially influential on a business level, do not impact the scientific and regulatory considerations underpinning substantial equivalence as per the FDA's requirements for a 510(k) submission. Therefore, demonstrating sufficient evidence for substantial equivalence is critical in the 510(k) review process.