A pre-market submission is required after a manufacturer has determined its class of device and the associated regulatory controls. Most Class I devices and some Class II devices are exempt from quality system requirements, but are still subject to regulatory controls.
Device product classifications can be found by searching the Product Classification Database. The database search provides the name of the device, classification, and a link to the Code of Federal Regulations (CFR), if any. The CFR provides the device type name, identification of the device, and classification information.
A 510(k) submission is a submission to the FDA to demonstrate that the device to be marketed is at least as safe and effective, being substantially equivalent to a legally marketed device and as such, is not subject to pre-market approval.
Pre- market Approval requirements apply to Class III devices, the most stringent regulatory category for medical devices. Premarket approval is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury.