What is the eSTAR?
In early 2020, The FDA Center for Devices and Radiological Health (CDRH) released the electronic Submission Template And Resource (eSTAR) electronic submission template for pilot use. FDA described the eStar as “an interactive PDF form that guides applicants through the process of preparing a comprehensive medical device submission.” The intent of the eSTAR program is to enhance the incoming quality of submission by providing a standardized format for submissions. If a submitter completes an eStar submission, then the submission is automatically accepted without going through the RTA process, as the eStar incorporates all the requirements of the RTA process for 510(k)s and de novos, and the requirements in associated 510(k), De Novo, and other premarket related FDA guidance documents.
The eStar program was developed based on the learnings from the Quality in 510(k) Review Program Pilot, which ran from September 2018 through May 2021. Currently, eStart supports 510(k)s and De Novo submissions. There are two versions of the template, one for non-in vitro diagnostic (IVD) devices and a separate one for IVD devices. While the use of eStar is voluntary at this point in time, it will be required for 510(k)s starting October 1, 2023 so it is important to begin gettting familiar with the form. The current eSTAR templates can be found on FDA’s website: Voluntary eSTAR Program.
As the eSTAR is a fillable PDF form, it contains questions for the user to answer. Depending on the selected answers to the questions the form subtracts sections that are not applicable, limiting the form to only necessary section.
In addition to including questions, the eSTAR includes sections, such as device description, that can be filled in, and also allows for attachments to be uploaded.
The eStar can also be used to address Requests for Additional information. In this case, the submitter is to revise the eStar and resubmit.
What are the challenges of the eSTAR?
While the eSTAR is intended to help make sure submissions contain all necessary data and are of sufficient qualities, it does introduce some challenges. Below is a discussion of some challenges, along with suggestions on how to overcome the challenges.
Challenge #1: The form is slow
Every time a question is answered on the form that changes which sections of the submission are shown or hidden, it takes the form time to update. While this may seem inconsequential it can become an inconvenience to consistently be interrupted in completing the form. To minimize this challenge, one just has to develop patience.
Challenge #2: The form does not provide an opportunity to track changes
Submissions are not typically compiled by a single person. Instead, various people on the product development team contributes various information to the submission. Various sections of a submission are often edited by more than one person. Without tracked changes It will be challenging to understand any edits made to the eSTAR if multiple project members are editing the document. To minimize this challenge, we recommend one person on the team be responsible for compiling the eSTAR.
Challenge #3: The form does not number sections
PDF forms provides a navigation menu on the left side that allows the user to view bookmarks, attachments or pages.
When the attachment option is selected it will show a list of the attachments. The list is provided in alphabetical order.
Often multiple sections may refer to the same attachment. However, typically an attachment has one specific home. For example, the device description or cleaning section may reference the user manual, the user manual is homed in the labeling section.
Numbering sections would be helpful because it would allow users to organize attachments in a logical way (for example, if Bench Testing was section 18, the appendices could be organized by Attachment 18-01, Attachment 18-02, and so forth.) This would allow for attachments to be easier to find when looking for them in the attachments menu.
In lieu of section not having numbers, we recommend having logical prefixes to attachments to organizing similar attachments in groupings. For example, all device description attachments having a prefix of AX, Labeling attachments have a prefix BX and so forth, where X represents a sequential number. A demonstration of this is provided below:
A1 – Console drawing
A2 – Electrode Drawing
B1 – Patient Manual
B2 – Physician Manual
Challenge #4: The eSTAR is very prescriptive in where attachments can be uploaded
The form identifies specific places where attachments can be uploaded. There are no options to upload an attachment if it doesn’t fit into a predefined option. One example of this is for Additional Information (AI) responses.
The form allows the user to upload revised attachments (such as revised user manuals). But, sometimes responses to AI deficiencies do not fit in a predefined attachment. For example, FDA may ask a specific question regarding the test set up of the EMC test report. It may not be appropriate or possible to update the report itself, and the explanation may require figures making it more than can be included in the deficiency text box. However, there is no attachment option directly in the deficiency area. Therefore, to work around this, the user will need to upload the explanation document in the EMC section and reference that attachment in the Deficiency text box.
Challenge #5: The form allows linking amongst the documents
Because the eSTAR form includes all attachment documents directly in the form, hyperlinks from one document to another document can be used. However, this cannot be done until both the attachment including the hyperlink and the attachment being linked to. If either of the attachments need to be removed and uploaded, then the hyperlink will be broken and will need to be re-established. Therefore, if utilizing this feature, it is best to do it once all attachments are finalized and uploaded in the form. This will require extra administrative time towards the end of completing the eSTAR. Be sure to include that in any preparation timelines developed.
Challenge #6: The form does not inherently support the telling of the story
A successful 510(k) is more than just answering questions and providing attachments. A successful 510(k) tells the story of the device, with that story connecting the various sections and nuances. It also tells the story of the attachments, explaining what is included in the attachments and how those attachments support a substantial equivalence determination. While it is still possible to tell a story within an eStar, by creating overviews for each section and providing them as attachments, it does not inherently encourage a submitter to do this. Additionally, as the order of a majority of attachments is pre-defined, even if you include an introduction section it may not be the first attachment related to a topic that the reviewer reads. In spite of this, it will likely be helpful to provide an introduction for each section that ties the story together.
Hopefully knowing these challenges, and the suggested work arounds, helps you in preparing an eSTAR submission.
What are the benefits of the eSTAR?
Despite its challenges, the eSTAR has several benefits, including:
- a consistent approach to providing submission content to FDA, which in turn hopefully supports quicker reviews by FDA
- results in one (1) document (the eSTAR), that includes all attachments within it. Therefore, you don’t have to be concern with making sure the eCopy is compiled correctly.
- removes the size restriction on an individual attachment (which is 50MB for eCopies)
If you would like Biologics Consulting’s expert guidance for your eSTAR submission, please contact us via our website and we will be glad to assist you.