US FDA Pre Market Submissions

The FDA 510(k) or Premarket Notification is applicable mainly to Class II devices as per FDA Classification intended for use on humans, with mild to moderate risks, before it can be marketed in the US. Some Class I and III medical devices also come under the scope of 510(k). This technical dossier is used to prove that the device is safe and effective. The request 513(g) is submitted to FDA for confirmation of classification, if the classification of the device cannot be determined. Pre-submission process is used by applicant to obtain feedback from FDA before actual submission for the 510(k) clearance.

The process for getting 510(k) clearance involves comparison of the device with one or more devices that are already marketed in the US legally. The applicants should claim and prove the substantial equivalence to the predicate device. To prove substantial equivalency, both devices should have the same intended use but any difference in the technological characteristics are overlooked as long as the safety and effectiveness are not compromised.


Is there any class II devices exempted from 510k? Can you mention any of them? Is there any reason for this exemption?