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New 510(k) Review Process

Once the application is accepted, FDA will conduct the review and either send you a substantially equivalent (SE) letter, or request additional information within the first 90 days. You may hear back from the reviewer in the first 45 days, but the internal review timeframe is 90 days. If you receive a written request for additional information in that first 90 days following acceptance, you’ll have 180 days to resolve all of the deficiencies through the interactive review process. 

The FDA no longer places 510(k) applications on hold. During interactive review, your reviewer is easily accessible. If the deficiencies aren’t resolved within that 180 day time period, the FDA will delete the submission and keep the user fee. Once the review is completed, you won’t have the luxury of immediate access to the reviewer.

The dental division reviews more 510(k)s than any other division, with abutment systems and bone graft materials 510(k)s needing the most follow up. Make it easy on your reviewer in any way you can. Take into account that each reviewer has as many as 10 active files, with as many as 20 applications waiting for additional information. When you receive a request for more information, organize the response:

  1. In a way that the reviewer can take the least amount of time to recall what they asked you and why.
  2. That allows them to relate your information to the questions they asked and quickly assess the additional information.