FDA 510 k Submission: A Step By Step Guide

510 k submission is given to FDA to reveal that the device or product to be marketed should be legalized as it is safe, effective, and successful. FDA has classified the devices underclass I, II, and III, which are considered for human use and for the devices which don't require premarket approval application. Class I devices are those who are of less risk for the public. This device doesn’t usually need 510 k submission. Devices under class II are those who are of medium risk and usually premarket clearance by FDA 510 (k) submission. Classes III devices category are of those are which are of full risk to the public and must fulfill the requirements, not 510k premarket submission. The device's manufacturer should submit a 510 k to FDA; otherwise, the device will be spared from 510 k premarket requirements of the FDA. Before the marketing of a device or product, every submitter of 510k submission must receive an approval in written format from the FDA. This approval means that the device is safe and can be used for commercial purposes and marketed across the country. 

510 k submission guideline

The submitter cannot market it's devices until he receives the approval, which declares that it is substantially equivalent. A substantial equivalence requires consideration under 510 k submission that they are equal to other legal devices in the market approved. If FDA doesn't require the devices as substantially equivalence, then the submitter has to resubmit the other 510 k with all new data. If the FDA approved the device as a substantial equivalent, it could be marketed across the country. The approval is made within 90 days by the FDA, as it depends on the details submitted by the submitter. The product can be marketed instantly only after the approval by the FDA. 510 k submission is required when a company introduces a new device into a market for the first time. 

Requirement for 510 k submission

510 k submission is also required when there is an alteration and change to a legally marketed device because that alteration or modifications can impact its safety. 510 k premarket submission is not required when someone is selling an incomplete device to another firm for further completion. If the device is manufactured outside the country and you are importing it, then you don't need 510 premarket submissions if the foreign manufacturer of that device has already submitted it. The categorizing and submission processes related to medical devices are very different from those provided for pharma products. That's why it includes that 510 k premarket notification.