As part of the FDA Reauthorization Act (FDARA) and the Medical Device User Fee Amendments (MDUFA IV) of 2017, the U.S. Food and Drug Administration (FDA) committed to developing electronic submission templates. The intent of these templates is to provide guided submission preparation tools, improve submission consistency, and enhance efficiency in the review process. Since the commitment was announced, the FDA has issued guidance documents on electronic submissions for medical devices, developed the electronic Submission Template and Resource (eSTAR), and launched the voluntary eSTAR Program.

A Brief Overview of the FDA eSTAR Program

The current process for regulatory submissions is to format submission documents in e-copy format, download them onto a flash drive, and mail the flash drive to reviewers. The FDA eSTAR program came from a desire to make it easier to do certain types of regulatory submissions and make them accessible to manufacturers online. 

The interactive system is designed to indicate which documents are required based on responses in the template, making the requirements more clear to manufacturers and delivering more complete submissions to reviewers. As you answer questions, it adds or eliminates sections from the template. For example, if you indicate that you have a nonpatient contacting device, the biocompatibility section will become inactive, so you don’t have to worry about adding information about biocompatibility.

Currently, the FDA eSTAR template can only be used to prepare 510(k) and De Novo submissions, but other types of submissions are in development, including premarket approval (PMA) applications. The system can be used for medical devices and IVDs, but it cannot yet be used for combination products, breakthrough devices, or other types of submissions. Many in the industry believe that the use of this template, which is currently voluntary, will eventually become required along with other electronic regulatory submissions.

Features of the FDA eSTAR Template 

One feature of the eSTAR template that helps streamline the submission process is that it populates the regulations and any recognized standards you might want to reference. This helps reduce writing time and reduces the chances of human error when typing regulations and standards. The system also integrates multiple resources (for example, guidance documents and databases), which helps streamline submissions. 

As you go through the various sections, the template provides prompts for additional attachments, which could include:

  • Device description
  • Engineering drawings
  • Software architecture design chart

As you go through the process, the system provides a visual indicator of what is complete and what still needs to be done. Completed sections are green, incomplete sections are red, and optional sections are gray. When all sections are green, the top of the document says, “Your file is complete,” making it easy to know that you have added content to all of the required sections. 

When getting started with eSTAR, it’s worth noting that there are some differences from an offline submission. For example, the way some of the attachments are requested is not immediately intuitive. Normally, engineering drawings are embedded in the device description. With eSTAR, attachments for engineering drawings and device descriptions must be uploaded separately. Despite having to make some adjustments, overall, the eSTAR template is easy to use and makes the submission process more efficient for manufacturers.

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Tips for Preparing eSTAR Submissions 

Like any other type of regulatory submission, there are a few best practices you can follow to make the process go more smoothly: 

1. Be organized.

Have a folder with drafts of all the different attachments that will go into the template, and name them according to the sections where they will be attached. With this approach, you have an internal checklist of the items that are complete in the file and what you still need to gather as you compile information.

2. Plan ahead.

When you get close to having all the information you need organized in a folder, start filling in the administrative sections of the checklist. The template will require sections based on your responses, so you can easily see if you’re missing anything. This approach will give you time to gather any documents that you don’t yet have so you can fill in the gaps before entering all of your information into the template. 

3. Be consistent.

The template is flexible in terms of document types, including Word, Excel, and PDF documents. You can also include demonstration videos and other types of content as appropriate. Although the system allows this type of flexibility, one best practice is to convert all text documents to PDFs because it maintains the integrity of the document.

Lessons Learned from eSTAR Submissions

Some of the best FDA eSTAR guidance comes from learning from prior mistakes. 

Gather signatures at the end.

If someone from the company needs to sign a digital form stating that the content is truthful and accurate, do not do it until you are absolutely certain every attachment is what you want and that nothing needs to change. Once a document is signed, it is locked in the system, and you have to clear all the signatures on the entire submission and then reattach the one thing you need to fix.

Stay organized.

Have good version control practices in place and use consistent file-naming conventions to ensure documents are complete and accurate. Use your internal folder organization to gather comments, make edits, and so on. Once you know something is final, put it in a folder with all other final drafts. 

Stay current.

Always double-check to make sure you’re using the most recent version of the eSTAR template. The FDA makes occasional updates, and it’s important to make sure the template you’re using is current.  

Align your attachments. 

Look at the eSTAR template before you start filling it out to see how attachments are split up, and make sure documents match attachment sections. This is especially important for companies that have done prior 510(k) submissions because your current system for organizing documents might need to change. This might also require pulling some content out of attachments. For example, if engineering drawings are embedded in the device description, they will need to be compiled into a separate document. On the other hand, some content may need to be compiled into a single attachment to conform to the template requirements.

Start with the questions.

Fill in the questions first, and then prepare the documents. Once the questions are answered, you’ll see the remaining 10-20 percent that needs to be completed by attaching documents.

How RQM+ Helps

RQM+ offers tailored services to match your regulatory submission needs. Whether you need a review of documentation that has already been produced, resources to write sections based from scratch, or something in between, our team is here to help. With a deep bench of former reviewers and regulatory subject matter experts, we can help you tackle any type of submission or regulatory issue.

When the FDA has questions about your submissions—whether they are through eSTAR or other channels—having good communication is key. RQM+ gathered a panel of experts to discuss your response options in this RQM+ Live! show: “When should we throw the least burdensome flag or appeal an FDA decision?”

RQM+ Live 40

 

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