Interactive PDFs Come to Pre-Submissions

How PreSTAR will speed and clarify FDA feedback


FDA is constantly improving their online processes, and we are excited about their latest upgrade for pre- submissions. Now, pre-submissions can be submitted using “PreSTAR”: an interactive, macro-enabled PDF template. At RQMIS, we’ve already begun appreciating the simplicity that this new format offers – fields are dynamically updated and all supporting documents and test reports can now be maintained from one place.

FDA introduced the new Pre-Submission eSTAR (PreSTAR) template and resources on June 9, 2023. Pre-Submissions are used to gain FDA feedback on limited key questions companies may have ahead of a full submission. For example, the FDA can provide feedback on your device’s regulatory strategy or V&V testing requirements. Previously, Pre-Submissions, like other types of Q-Submissions (SIR Q-sub, Breakthrough designation Q-sub, Informational meeting Q-sub, Study Risk Determination Q-sub) were prepared and published to FDA only via eCOPY – electronic but static PDFs.

Advantages of PreSTAR

Currently, preparing and submitting the Pre-Submission through the PreSTAR template is considered voluntary. However, we already have begun using them with our clients and have seen the following advantages:

  • Keep things in one place; since the PreSTAR interactive PDF is a fillable template, we can easily edit word documents which are attached and saved within the PDF.
  • Ask multiple questions within the chosen topic category; the PreSTAR allows us to obtain feedback from FDA on multiple specific topics (minimum of four areas), with multiple questions on each area.
  • Focus on specific topics and build supporting documentation around Pre-Submission Questions. The new format provides clarifying structure, keeping key client questions at the forefront.

The introduction of interactive PDF templates is only the latest of FDA initiatives to move from traditional (paper or DVD) to increasingly modern submission modes. (preSTAR interactive PDF). As FDA makes these changes, our Regulatory experts at RQMIS are constantly gaining experience to take advantage of the latest technology for preparing your submissions for fast, efficient efficient feedback from FDA . Contact us and we will get you up to speed with the latest submission formats.

If you are interested to know more about interactive PDFs for 510(k) submissions, please don’t forget to check out our recent blog on 510(k) eSTAR, “Are you ready for the eSTAR 510(k) transition? Contact RQMIS today to craft your eSTAR FDA submissions”.

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