As you must know by now, the FDA made eSTAR 5.0 mandatory for 510(k) submissions in October 2023. It’s also available for de novo and PMA submissions on a voluntary basis (for now), and while it certainly does streamline things, there are some key revisions in 5.0 that you need to be aware of to minimize impact on your submissions.
Designed to be a one-stop shop for crafting comprehensive medical device submissions, eSTAR 5.0 guides you through the process with automated features and content that aligns perfectly with FDA’s internal review process. Plus, it integrates helpful resources like guidance documents and databases, and offers step-by-step instructions for each section.
Let’s start with the positives, shall we?
- From PUSH to PULL: Before eSTAR, the FDA would “pull” documentation from manufacturers through requests and interactions. This meant a lot of back-and-forth, a lot of paper, and a LOT of aggravation on both sides. eSTAR 5.0 flips the script to a “push” method, prompting manufacturers to submit more complete and accurate information upfront. This interactive format ensures you’re providing the right content based on your submission type (think pre-market notification or PMA).
- Farewell Refuse to Accept (RTA): Your submissions won’t be rejected due to automatic eSTAR 5.0 template verification, which theoretically leads to a faster review. However, some haven’t seen a difference, and it can still take weeks – which is no better than the old RTA process. There’s still a technical review.
- Alignment with FDA Templates & Guidance: eSTAR 5.0 aligns with the FDA’s internal review templates, streamlining the process for reviewers and potentially making it more efficient. It also integrates guidance document expectations, and provides helpful examples.
- Error Messages & Helpful Hints: eSTAR 5.0 throws up error messages if your answers contradict each other (e.g., wireless technology but no software), and a blue question mark offers additional context to help you answer correctly.
But this is an FDA project after all, and therefore subject to the usual persnickety particulars that mark any sizable agency project:
- Specific Software Requirements: You’ll need specific software to use it – Acrobat Pro (latest version for Windows) or Foxit are your go-to options – and you need to be sure you have the latest version of eSTAR, so double-check for minor revisions (like version 5.1).
- Template Instability: eSTAR 5.0 crashes can happen often, potentially causing inconsistencies in your submission, so be sure to save often to avoid losing all that data you just entered.
- Limited Control & Readability: The standardized format can be clunky and doesn’t always read well. Critically, the auto-generated 510(k) summary might not be suitable for public consumption, and including too much detail in the technological comparisons and device descriptions could be risky.
- Collaboration Challenges: eSTAR’s limited space for viewing text makes reviewing and editing cumbersome, and it doesn’t track changes, making collaboration with reviewers or multiple authors difficult. You might want to consider having your team work in separate Word documents and copying all your finalized content into eSTAR.
The attachment process is different – and a bit clunky – and is the change that has generated the most questions. Here are some tips to help you get around the most frequently seen issues:
- Combine Attachments: Aim for one attachment per eSTAR 5.0 question. Pagination can be tricky, so combining attachments with bookmarks and clear naming conventions is key.
- File Types: eSTAR 5.0 allows PDFs, Word documents, Excel documents, MP3s, and MP4s, but .zip files are a no-go due to security concerns. Be sure to check the FDA website for the complete list of accepted file types.
- Public vs. Private: Remember that anything in a yellow header text box could be public-facing, so keep proprietary information out of these boxes and include it in attachments.
- Traceability: eSTAR 5.0 integrates traceability information from relevant guidance documents to ensure the FDA can easily see how your submission aligns with established guidelines.
- Previous Submissions: Attach full versions of past submissions and interactions with the FDA, including non-substantial equivalents and withdrawals. Don’t try to hide my omission – the FDA has a VERY long memory and will find that submission you didn’t think you needed to reference. File size can become an issue here, so combining attachments strategically can help.
- Content Cleanup: eSTAR streamlines content by eliminating unnecessary sections like the submission cover sheet, indications for use form, and class three summary statement (unless using the PMA version). Financial disclosures are still required but not included as a separate section.
- Decision Summary Reports: No need to worry about these – eSTAR 5.0 generates them automatically!
While eSTAR 5.0 certainly has its weaknesses and quirks, the strengths and the opportunities it presents outweigh the challenges. By being aware of the limitations, you can minimize their impact and make eSTAR work efficiently for your organization.
But this is just the beginning, and there’s a lot more to unpack, namely the changes regarding cybersecurity, biocompatibility, and clinical investigations. We’ll delve deeper into these specifics in a future post.
Get all these juicy details and more in the eSTAR 5.0 webinar video on my YouTube channel: https://youtu.be/6rUTywLw7cY
And learn more about what makes a good submission strategy here: https://leanraqa.com/fda-submission-strategy/
