5 eSTAR Challenges MedTech Regulatory Teams Must Overcome

Introduction

Starting October 2023, MedTech regulatory affairs teams will have only one way to file FDA 510(k) submissions for their medical devices electronically via the new eSTAR format.

Only PMA submissions will be exempted from this requirement. 

This makes it imperative for MedTech regulatory affairs teams to understand, plan for, and operationalize against this major change in filing requirements. Failing to adequately plan for the new eSTAR format will have detrimental consequences that limit or jeopardize the commercial value of both new and existing medical devices and significantly raise operational costs. 

According to FDA data:

• 71% of submissions have additional information requests

• 34% of submissions result in a refusal to accept

• 7% of submissions generate a technical hold

The organizational impact of the above is already imposing what can amount to millions of dollars in administrative costs and lost commercial potential through: 

1. Submission Delays: eSTAR imposes a costly and continually-changing process that MedTech regulatory teams have to staff and continually operationalize against. This slows down submissions and raises the odds of marketing delays.

2. Training/Learning: eSTAR streamlines the FDA review process but increases learning and training costs for MedTech regulatory affairs teams - due to the fundamental limitations of the Adobe’s format it uses

3. Administrative Overhead: regulatory affairs teams have to create unique templates, attachment trackers, processes, and communication plans for eSTAR due to its departure from historically accepted eCopy for 510(k)s

FDA eSTAR: Challenges for MedTechs

The first thing that manufacturers must realize about the FDA’s eSTAR program, is that it was intended to accelerate the FDA’s process - not theirs. According to the FDA, “[eSTAR was created] to improve submission consistency and enhance efficiency in the review process.”

While eSTAR will have a net positive impact on market access by streamlining the FDA’s regulatory review process, it is already placing a larger undue burden on MedTech regulatory affairs and quality risk management teams. In order to understand this burden, and how to navigate it, we must first understand what eSTAR is.

What is eSTAR? The Good.

eSTAR is a 21-page interactive PDF document that structures a 510(k) submission process within an interactive PDF form. Essentially, eSTAR is intended to create a format for all 510(k) submissions, reducing the variations in style, organization, and structure that the FDA receives for MedTech devices. It provides a visual indicator of completed sections in green, incomplete sections in red, and optional sections in gray. When all sections are green, the top of the document says, “Your file is complete,” making it easier to see the overall completeness of the required sections. 

The eSTAR PDF is designed to indicate which documents are required based on responses in the template, making the administrative requirements more clear to manufacturers and delivering more complete submissions to reviewers. As you answer questions, it adds or eliminates sections of the template.

eSTAR also allows the selection of regulations and any recognized standards you might want to reference, to help reduce writing time and chances for human error when typing regulations and standards. Technical files can be attached to the document, with some limitations around size and numbers of files.

eSTAR’s Limitations & Challenges

While it’s good that the FDA is standardizing regulatory procedure, using this type of long Adobe PDF form for regulatory submissions has a number of drawbacks:

FDA’s eSTAR Limitations

• Blanks out entered information if input order incorrect

• Can only be edited one user at a time (technical limitation with Acrobat Forms)

• Expensive to support as new versions are released up to few months

• Slows down as you add attachments

• Has no true error checking, increasing “technical rejection” risk

  
  

From the beginning of the broader eSTAR rollout in early 2023 (when a larger group of MedTech organizations started experimenting with eSTAR) the stories started rolling in. In its defense, a number of eSTAR’s challenges actually stem from the limitations in the format in which it is edited and delivered: Adobe Acrobat PDF.

Challenge #1: Big PDFs = Big Room for Technical Issues and Human Error

Because the eSTAR file is complex and field-dependent (depending on your answers, new fields appear), the document is sometimes too complex for Adobe Acrobat. Fields get blanked out if they are answered in an incorrect order, and every attachment you add to the document slows it down significantly. Regardless of whether you get red, grey or green markings on the in-line eSTAR checks, field content is never actually checked - the template can only tell if something is filled in or not. This means that you may have contradicting or mismatched answers to similar questions that turn the field indicators green, but inevitably lead to a technical rejection of the submission (once reviewed by a human). There is no true error checking in eSTAR - you cannot simply go by fields turning green.

Challenge #2: No Collaboration in Adobe Acrobat Forms

PDF form documents are not collaborative - and yet a 510(k) submission process inherently is. It has to be. Up to 7 different teams are involved in gathering technical files, drafting and editing a 510(k) submission, finalizing and submitting it, and then monitoring and communicating with regulatory bodies post-submission. PDF forms can only be edited one user at a time - which creates a need for regulatory teams to draft their own eSTAR word templates for collaboration and drafting purposes. Technical files float around shared drives (such as sharepoint, box, dropbox, etc) and work is immediately fragmented across multiple mediums and channels.

Challenge #3: eSTAR Changes Every ~2 months

The FDA is changing the eSTAR template about once every 2 months. This means that just when you craft a process around the current version and get your first submission drafted, the next version of the template is out. Now you have to go through the template, see what has changed, update your current process and mirror documents and augment any missing content and formats. This creates an incredibly high organizational burden on regulatory teams and their collaborators.

Challenge #4: Some File Formats Have Changed

eSTAR presents some key non-intuitive differences in the way attachments are submitted. For example, engineering drawings will now need to be compiled into a separate document, while some content may need to be compiled into single attachments to conform to the template requirements.

Challenge #5: Get Ready for Rejections >71%

All of this is inevitably leading to higher rejection risk. According to the FDA, 71% of 510(k) submissions result in requests for additional information or outright technical rejection. 

How to get ready for eSTAR?

So, how can MedTech regulatory affairs teams adapt to the FDA’s new eSTAR submission requirement? 

1. Templates: Create and maintain a master template for each eSTAR submission outside of the actual eSTAR document itself. This will allow for collaborative authoring ahead of submission time. 

2. Files: Gather and consistently name and number all technical files in one secure drive, but do not attach them to the template until submission time. Create a shared internal checklist for file readiness, containing attributes such as names of contributors and file due dates.

3. Planning: eSTAR adds days to submission timelines - so you should allot extra time in your project plan for eSTAR, covering additional time for file conversion and labeling, eSTAR template compilation, review and ongoing maintenance of eSTAR versions. 

4. Training and Standard Operating Procedures (SOPs): Companies should allocate 2-4 weeks of training time to deal with process changes due to eSTAR. Since the FDA provides only a 2 month window of allowable use for previous versions of the template, rapid sprint cycles will need to be planned with every major version release of eSTAR. Due to compliance implications, each procedure also needs to be rapidly documented.

Or, use the World’s only Native eSTAR Submission Builder by Essenvia

Essenvia has created the world’s only native eSTAR builder for MedTech regulatory teams trying to address each of the challenges presented by FDA eSTAR. Powered by Essenvia’s regulatory submission platform, eSTAR on Essenvia accelerates the eSTAR submission process, generates a ready-to-submit eSTAR file and makes your eSTAR information available for re-use in MDR, IVDR and future eSTAR submissions.