In this video we review the new eSTAR templates for a 510(k) submission and we include information from the new FDA eSTAR draft guidance. We also addressed questions that were unanswered in our previous eSTAR training with responses directly from the FDA and from a third-party reviewer.
On September 29, 2021 the FDA released the new eSTAR draft Guidance for 510k submissions. This is a huge milestone because there have not been any draft guidance documents created for pilot programs. The draft indicates that the comment period will last 60 days (i.e. until November 28, 2021). However, the draft also states that the guidance will not be finalized until a date for requiring electronic submissions (i.e. submission via an ESG) is identified. The draft indicates that this will be no later than September 30, 2022. Once the guidance is finalized, there will be a transition period of at least one year where companies may submit via an ESG or by physical delivery to the FDA DCC.
There are no new format or content requirements in the eSTAR draft guidance, but the eSTAR template itself has several text boxes that must be filled in with summary information that is not specified in the guidance for format and content of a 510k. The information requested for the text boxes is a brief summary of non-confidential information contained in the attachments of the submission. Therefore, these boxes can information that would normally be in the overview summary documents that are typically included at the beginning of each section of a 510k.
If you are interested in downloading our template for the eSTAR cover letter and the table of contents planning tool, please fill in the registration form our on website. We will also notify you of new updates to the eSTAR template for 510(k) submissions.
