Submitting a 510K

If you would like to market a medical device, chances are you’ve looked into submitting a 510k. A 510k is a submission to the Food and Drug Administration (FDA) for a device that does not require a Premarket Approval (PMA) application, but it is a Class I, II, or III device that is substantially equivalent to a device that is already marketed. A Class I device is a device with the least amount of risk to human health and safety, such as bandages. While Class III devices have the highest amount of risk to the patient, such as pacemakers. These devices have high amount of risk due to being implanted and in constant contact with the tissues of the patient, and they may be used to support human life.

 

Typically, most 510k submissions are for Class II devices; there are very few Class I and Class III devices that follow the 510k pathway. A Class II device, as expected, falls in the middle of these two classes. These devices typically come in contact with the patient for longer periods of time than that of a Class I device but are not implanted like a Class III device may be. Examples of devices that may be in Class II are catheters, contact lenses, and dental retainers. 

Your device will have a classification, product code, and designated review panel. The FDA has established classifications for around 1,700 generic devices which fit into 16 different medical panels for review. These 1,700 generic devices all have been assigned to one of the three regulatory classes.

To submit a 510k, there must be a device already on the market that is substantially equivalent to the device that you are trying to gain FDA clearance for. A substantially equivalent device is the device that is similar to your device in safety, efficacy, technological characteristics, and indications for use. You will use this device to prove to the FDA that your new device is as safe and effective as the already marketed device. The more similarities between the subject device and the predicate device, the stronger your argument will be for substantial equivalence.

 

Proving substantial equivalence is the basis of your 510k submission. When referencing the already marketed device that you are trying to prove substantial equivalence to in your 510k, it will be called the “predicate device”. The device you are trying to get clearance for will be considered the “subject” device throughout the 510k submission. 

For the submission, there are many sections that revolve around proving the substantial equivalence of your device. Part of this submission will be forms that are provided by the FDA for use in your submission. There are also many other sections that are required in the final 510k submission for which the FDA provides guidance for. In total, your 510k submission will have 20 sections that cover a wide range of topics regarding your device such as the 510k summary, device description, and proposed labeling. 

After following the FDA guidance and preparing for the submission, it is time to submit your 510k to the FDA. Currently, the FDA is transitioning from mailing the submission to submitting through an electronic portal. In the past, the 510k submission would have to be zipped and encrypted using the FDA’s eCopy Software, downloaded on a flash drive, and mailed to the FDA Center for Devices and Radiological Health (CDRH) office in Maryland. Before the eCopy could be sent, payment for the 510k must have been received by the FDA and referenced in your submission to ensure the payment had been made. Over the next few months, the FDA is moving to an electronic format to submit all 510k files. The new online software is called the eSTAR program and will allow for 510k submissions to be completed electronically without the need for mailing in a physical 510k submission.

 
After the 510k has been submitted to the FDA, you will receive a Receipt of Acknowledgement. This document will provide you with your assigned 510k number. If your user fee for the 510k submission has not been paid, you will receive a Hold Letter from the FDA. This letter will inform you that a payment must be made in order to continue the 510k process. Once the payment is made, the 510k process will continue. If you do receive a hold letter, you have 180 days to respond and resolve the issue, otherwise the submission will be withdrawn from the FDA’s system and a new submission must be created for the device. 
 

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The next step in the 510k process is the Acceptance Review. In this stage, the FDA will review your 510k submission to ensure that it holds the minimum necessary information that is required to enter into the next phase, which is Substantial Review. This decision must come from the FDA within 15 days of receiving your Receipt of Acknowledgement. If there is no decision received, your 510k will automatically move into Substantial Review. If the FDA does respond within the 15 days, and your 510k does not pass the Acceptance Review, it is placed into a Refuse to Accept (RTA) hold. If the FDA places an RTA hold on your submission, you will have 180 calendar days to respond to the hold. 

An RTA hold could be placed for many reasons. The FDA uses the Acceptance Checklist, which is included in Appendix A of the “Refuse to Accept Policy for 510ks” document provided by the FDA, to review the 510k submissions. When the review begins, the assigned FDA reviewer will use this checklist as a guide to sort through your submission. There are 43 questions included in this checklist that requires “yes”, “no”, or “N/A” to each of the questions on this checklist. The list covers all sections of the 510k submission to ensure that all necessary information is included in your submission. 

 

 

 

 

 

 

 

 

 

 

 

 

 

If you are to have an RTA hold placed on your 510k submission, you will receive the checklist that has been completed by the FDA reviewer. Each of the questions that caused the RTA hold to be placed on your 510k submission will be marked in yellow and there will be comments from your FDA reviewer regarding the questions they may have. There may be only one section that caused the RTA hold to be placed on the 510k, or there may be many sections that could require your response. There are many reasons why the FDA may ask questions, including missing information, or additional testing requirements to prove that your device is substantially equivalent. Before submitting your 510k, it may help to review and complete the same 510k checklist that the FDA uses to review your submission. This could help you catch simple mistakes and ensure all required information is present to ensure your submission is as complete as possible.  

The RTA response must be sent back to the FDA using the eCopy mailing service, or in the future, the electronic service. Unless requested, the entire updated 510k submission does not have to be resent. Only the updated sections and the responses to their asked questions need to be sent back to the FDA. Once the FDA reviews your response, they will either issue another RTA hold is they have additional questions, otherwise you will receive acceptance into Substantial Review. 
 
Once your 510k submission is in Substantial Review, the FDA has two options for communication with you, which are Interactive Review or an Additional Information (AI) request. If an Interactive Review is chosen, this means that your submission will not be placed on hold and the communication will be through phone calls or emails. For an AI request, your submission will be placed on hold, and you will have 180 days to respond to this hold. An AI request is typically for longer, more substantial questions that may take more time to answer. 
     
Once your submission passes this final phase of review, you will receive a 510k decision letter. This decision letter will state whether the FDA has determined your subject device to be substantially equivalent or not substantially equivalent, with the goal being for your device to be substantially equivalent to the already marketed device you have chosen to be your predicate. This means your device is now considered “cleared” and your work on your 510k submission is complete. 
 
As explained above, a 510k FDA submission has many important steps to complete in order to gain clearance from the FDA. Your device will fit into one of three medical device classes, but most 510k submissions are for Class II devices. The submission contains 20 sections that must be completed with the guidance of the FDA. Your submission will be based on the similarities of your subject device to the selected predicate device. Proving substantial equivalence is the key to your submission.

 

 

 

 

 

 

 

 

 

 

 

 

 

Once your 510k has been submitted, it will be reviewed by the FDA to determine if your submission holds the minimum information required. From this phase, you may enter an RTA hold or move into Substantial Review. Once you are in Substantial Review, you may enter Interactive Review or have an Additional Information request.

 

After this final stage, you will receive a 510k decision letter. This letter will detail if your device has been determined to be substantially equivalent or not. If your device is determined to be substantially equivalent, you will have received clearance from the FDA, and your 510k process is complete!