People who want to market their either Class I or Class II device products in the U.S, and the device is not exempt from 510(k), must file a Premarket Notification with the FDA, it is also known as FDA 510(k) submission. The 510(k) is a complex application to the FDA, because the application is to demonstrate that the device is safe and effective, and it is equivalent to another device which is on the market.

510(k) is a premarket technical document submitted to the FDA before a product enters the U.S. market to demonstrate that the product has the same safety and efficacy as a legally marketed comparable product in terms of intended use, design, materials, implementation standards, etc.

Who Must Submit a 510(k) Submission?

In general, manufacturers and specification developers who introducing a new device to the U.S. market; as well as repackers or relabelers who make labeling changes that significantly affect the device of safety or effectiveness must submit a 510(k) to the FDA. 

What Are the Steps of the 510(k)-submission Process?

l Step1: the company or sponsor must submit an eCopy or eSTAR of 510(k) applications to the agency.

l Step2: after the company sponsor submit 510(k) to the FDA, and when the FDA receives the submission, they will issue either an acknowledge letter or a hold letter. Typically, a holder letter issued includes the following reasons: the user fee has not been paid or a valid eCopy or eSTAR has not been provided. Additionally, it is need to notice that an acknowledge letter is NOT a marketing clearance letter.

l Step3: at this step, the FDA conducts an Acceptance review based on the FDA guidance Refuse to Accept (RTA) Policy for 510(k)s, then the applications are either placed on RTA Hold or accepted for Substantive review.

l Step4: During the substantive review process, the lead reviewer conducts a comprehensive substantive review of 510(k) submission. The goal of this step is to determine whether a substantially equivalent decision can be reached.

l Step5: if the FDA reviewer consider does not have sufficient information to make an SE decision, they may consider Interactive Review. If the FDA chooses to continue with an Interactive Review, they will be using tools with telephone call or email communicates with the submitter. During the interactive review, the FDA reviewer may request additional information from the submitter. If the reviewer issues an Additional Information (AI) request to the company sponsor, the submission will put on hold.

l Step 6: after review, the FDA will issue a 510(k)-decision letter which is also a letter of final decision. If a 510(k) that receives an SE decision is considered "cleared“. If the submission cannot be cleared, the FDA suggest that the submitter voluntary withdraw the application to keep the information confidentially.