The FDA eStar Program: Obligation or Opportunity?
With the eStar program The FDA wants to increase the efficiency of approval processes (e.g. the 510(k) process) through digitalization. The Johner Institute is working with the FDA to further develop eStar.
In this article you will find out how far-sighted this approach is and whether you should or even need to take part in it.
1. What is the eStar program?
The eStar program allows medical device manufacturers to submit their regulatory submissions to the FDA via an interactive PDF.
a) Interactivity
Interactivity has several aspects.
Built-in error checking
The PDF highlights areas where the data evidently still contains errors in red and corrected areas in green (see Fig. 1).
Automatically show and hide areas
The interactive document shows or hides areas depending on your selection. For example, the document automatically shows the software documentation details if you select that the product contains software or is stand-alone software (see Figure 1). The FDA defines this logic for showing and hiding in Schematron files (see Fig. 2).
Integration of attachments
PDF allows you to add attachments. From the FDA’s point of view, these appendices should even be included. There are no restrictions on the data format. Only the size of the resulting PDF document is limited to 1 GB (see Fig. 3).
Import and export options
All data except attachments can be imported from XML and exported to XML via PDF.
b) Electronic submission
Now the transmission no longer takes place on a physical data carrier, but electronically. Depending on the responsible FDA center, manufacturers submit requests via the CDRH portal or via the ESG Gateway for CBER-related communications.
c) eStar versus eCopy
The eStar program represents the next evolutionary step in digitalization after the eCopy/eSubmitter program. With the eCopy/eSubmitter program, the FDA has “only” specified the electronic submission file formatting that manufacturers must follow. There is no predetermined structure of the documents themselves or even structured data as in the eStar program with the eCopy/eSubmitter program.
If you would like to learn more about the history of these two programs and would like a comparison, we recommend taking a look at this guidance document.
2. Who can or can use the eStar program?
The eStar program is obviously intended to support medical device manufacturers in compiling and submitting approval documents more quickly and in better quality. But it is not aimed at all manufacturers and is not suitable for all approval procedures.
The eStar program is only applicable for:
However, it is not applicable for
- The PMA admission process
However, this seems to be expected, at least the PDF already contains this option, even if it is currently greyed out.
Participation in the eStar program is explicitly voluntary, with the exception of 510(k)s. Here it is mandatory.
Manufacturers and products for which the process is applicable may, but are not required to, participate.
3. How does the eStar program help?
The eStar program benefits manufacturers and the FDA.
a) Better quality documents
The FDA receives documents in higher quality because PDF helps manufacturers avoid obvious errors such as missing information or typos (for example in product codes). For example, drop-down lists and checking the completeness and consistency of content contribute to this.
b) More security
The PDF verification highlights incomplete or missing information both at the individual date level and at the entire document level (see Figure 3).
c) Less effort
Manufacturers and the FDA are spared the RTA correction cycle. However, the rest of the process remains unchanged:
The remainder of the 510(k) review will be conducted according to FDA guidelines, “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications” [510(k)]”, following the procedures identified in 21 CFR 807 subpart E. A De Novo review will be conducted according to the FDA guidelines, “De Novo Classification Process (Evaluation of Automatic Class III Designation)”, following the procedures identified in 21 CFR 860, paragraph D.
The FDA is not required to copy and paste the contents into its systems. This also saves effort.
Furthermore, the authority finds documents more quickly because access to the contents and attachments is possible directly via the PDF document and because manufacturers are forced to fill in the attachments in the structure specified by the FDA. This also saves the work of the authority. However, it does not promise shorter processing times.
4. Evaluation of the eStar program
a) Positive
The FDA uses this program to help manufacturers compile complete, consistent, and accurate documentation. The authority itself benefits from this, automating many preliminary checks.
This in turn benefits manufacturers because approval processes run faster and, in particular, unnecessary iteration cycles (including RTA tests) can be avoided.
The structure of the PDF document (see Fig. 4) and the division of attachments provide producers with valuable tips for structuring their documents – both at the document and directory level and within documents.
b) Criticism
The ability to import XML may at best be an interim technology for transferring information from existing systems into the FDA PDF document. This is still better than manual copy and paste, but it doesn’t replace an API.
The FDA provides the required attachments. This forces manufacturers to fill out their paperwork specifically for the FDA. This leads to the usual hard work of those responsible for regulatory affairs. Tasks that complete the digitalization of processes could and should make them superfluous.
The PDF may also contain errors. We were unable to enter the data in the Quality Management section, even though it appears in the summary (see Fig. 4). The guidance document does not address this section.
The obligation to deposit the electronic document on a physical medium appears somewhat absurd in the context of digitalisation. However, the testing phase for electronic sending via upload has begun.
c) Evaluation and prospects
With the eStar program, the FDA takes a significant step forward over many Notified Bodies with their “Application Forms”. These often fail to keep up in terms of functionality, usability and interoperability (XML import and Expert).
Interactive PDF is software that needs to be validated and further developed like any other software. So far, updates from the FDA have been made very promptly. For example, the new guidance document for the software has now been implemented by distinguishing between “Basic Documentation” and “Advanced Documentation”.
d) Comparison with the DZP
The eStar program is a step in the right direction. At the same time, it will consolidate this incomplete level of digitalization for years to come.
It would have been desirable if the FDA had already achieved the same level of digitalization as the Johner Institute’s Digital Approval Platform (DZP):
- (Mostly) complete capture and control of structured data instead of capturing attachments and text fields that cannot be evaluated by the computer. eStar uses a text field for the full purpose, including characterizing users and patients.
- Sending (almost) without documents
- Largely complete automated control of all data
- Full access to all data via API and therefore integration into existing systems of manufacturers and authorities or notified bodies
- No media interruptions and, above all, no need to convert information into documents (paper, PDF) or even send it via physical storage media
- Support throughout the entire process up to final approval or rejection, including feedback from the notified authority or body
5. Conclusion
a) Summary
With the eStar program, the FDA takes a further step towards the digitalization of approval processes. It takes what can be achieved with a document- and PDF-based approach to the extreme.
The interactivity of PDF documents with integrated application logic and a mix of structured data and attachments gives an idea of what would be possible with fully automated capture and verification of regulatory data.
Until then, manufacturers must work with the documents and adhere to the following guidelines:
- The existing guidance document “Providing Regulatory Submissions for Medical Devices in Electronic Format — Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act,” although no longer entirely current as it predates the eStar program, has been published and don’t not contain it yet.
- Even more important is the new guidance document “Electronic Submission Template for 510(k) Medical Device Submissions.”
The Johner Institute supports manufacturers and notified bodies in digital transformation. Interest? Then contact us now!
Version history:
- 2024-08-20: Revisions moved to new chapter 4. Numbering implemented consistently. Added introduction. Chapter 1.a) restructured and integrated with an image of the Schematron file (Fig. 2).
- 2023-09-15: Added information on electronic submission and eSTAR availability for combined products.
- 2022-09-23: Added information on the new eSTAR guidance document
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With the eStar program The FDA wants to increase the efficiency of approval processes (e.g. the 510(k) process) through digitalization. The Johner Institute is working with the FDA to further develop eStar. In this article you will find out how far-sighted this approach is and whether you should or even need to take part in…