510(k) submission checklist to get your medical device to market


    A 510(k) submission checklist can be a valuable tool for medical device companies going through their first premarket notification process.

    Did you know the FDA rejects more than 75% of 510(k) applicants? Unfortunately, even the slightest delay or setback in your 510(k) submission could spell disaster for your medical device company on its route to the US market. The sooner your device is cleared, the sooner you can start turning your cash flow in the right direction.

    With a greater understanding of the FDA 510(k) process and the steps you'll need to take along the way, you can drive a confident and successful submission that gets your device cleared first time.

    We built a 510(k) submission checklist to help you on your way! Access below.


    The 510(k) submission steps


    A 510(k) is a premarket submission made to the FDA to demonstrate that your medical device is safe and effective. U.S. medical device companies are required by law to submit an FDA 510(k) application.

    Here's a quick overview of the FDA 510(k) process and timeline.


    1. Submit your application


    Your application should be submitted online to CDRH or CBER's document control center. You can find out more about the electronic submission program and how to submit your digital application by visiting eCopy Program for Medical Device Submissions.


    2. Acceptance review


    After you've submitted your application, the document control center will send it to the appropriate ODE or OIR Division for acceptance review. A lead reviewer is assigned to your application. Within 15 days, you should receive the lead reviewer's contact information, as well as the status of your application.

    Those applications that are not accepted will be placed on an RTA hold. Applicants are given 180 days to address issues. Failure to do so may result in a withdraw.


    3. Substantive review


    During the substantive review, the lead reviewer will contact you within 60 days of receiving your application via email or a phone call to let you know if you’re ready for the interactive review, or if they need more information from you to make a decision.


    4. Notification of approval or rejection


    The last step, step four, is when the FDA sends you a decision letter to notify you of clearance or rejection. This whole process should happen within 100 days, according to the FDA’s website.


    RELATED READING: Everything you need to know about the FDA 510(k) submission


    510(k) submission checklist


    Of course, Step 1 is the one which concerns you.

    It's the part where you assemble everything the FDA will need to see to make a decision about your device, and determine whether or not to clear it for use in the United States.

    In 2022, 30% of 510(k) submissions weren't even accepted for initial review and were bounced straight back to the submitter.

    The reason? The submitting medical device company got something wrong. They missed a document, failed to include the right data, or did something else which made their application ineligible for completion.

    Qualio's team of medical device quality management experts have assembled a comprehensive 510(k) checklist to ensure you include everything you need to in your submission.

    Download 510(k) submission checklist here