When a product requires premarket submission, FDA will verify the declared 510(k) or PMA by comparing the submitted information to CDRH’s data systems. If the 510(k) or PMA information and number is not supplied, or is incomplete or inaccurate, it may delay the review of your entry.
If the information submitted matches the CDRH data system, then compliance is verified; if the information does not match, FDA may gather additional information or may detain the product. If the product requires a PMA or 510(k) and does not have one, it will be subject to refusal.
