6 Tips to Avoid 510(k) Submission Delays

6 Tips to Avoid 510(k) Submission Delays

August 30th, 2013 // 3:15 pm @

We often get questions about how medical device companies can minimize delays with FDA in having their device cleared.  Note that some delays are not in the hands of the submitter, but there are surely some easy steps that you can take that will streamline the 510(k) submission process. Here are some easy tips to ensure that your 501(k) submission is reviewed and approved quickly:

  1. Do all of your homework! You should ensure that you have thought about all of the latest requirements for your medical device. There are many guidance documents and ISO standards that may be relevant for your device. If going through these documents is difficult, consider hiring a good consultant to help you during the design of the device and its development. That way you can ensure that your 510(k) submission has all essential information.
  2. Do a pre-submission meeting. FDA has expanded its pre-IDE meeting program in recent years. Such meetings can be really useful for getting FDA guidance about specific questions that you need to address before you make a premarket notification submission. They also are helpful to see what areas FDA may want more information or testing on.
  3. Pay user fees. Most of your 510(k) submissions have a user fee, which you need to send in before or at the time you make your submission. If you do not pay the fee, the application is not complete and FDA will not accept it. We recommend that you pay the fee in advance, before you submit.
  4. Make sure the submission is of high quality. FDA and CDRH often cite poor submission quality as the top reason for delays in the application process. You need to verify that your submission is really complete! Submit all final reports in your application package; submit draft reports only in a truly exceptional case. Also, you should submit electronic copies of the submission.
  5. Do not guess! If your submission comes back with questions, you should get in touch with that branch of the agency and ask a lot of questions. Find out what the FDA wants.
  6. Give only what is required. When you submit a 510(k), you should not confuse the FDA reviewing office with extra information. Keep your content focused on what the agency needs to know to make a substantial equivalence decision.

Have more questions about your 510(k) submission? Check out our popular 510(k) webinar in September.


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