The electronic Submission Template and Resource (eSTAR) is an FDA submission tool that guides applicants through the process of preparing a medical device submission. It is free and available for voluntary use by anyone wishing to submit 510(k)s and De Novo requests to the Center for Devices and Radiological Health (CDRH) or the Center for Biologics Evaluation and Research (CBER).
Simply an interactive PDF form, the eSTAR, is designed to improve consistency and enhance efficiency in the FDA review process through automation, integration of resources, and current FDA guidances. It also helps in constructing each submission section to align with the content of the FDA 510(k) review memo template. As the application is automatically verified for completion, the FDA does not intend to conduct a Refuse to Accept (RTA) review for eSTAR submissions which will also help to speed up the review process.
Starting October 1, 2023, all 510(k) submissions, unless exempted, must be submitted electronically using eSTAR. Now is the perfect time to get familiar with the eSTAR application and the following article offers five tips to keep in mind when using the application for the first time.
Use the Correct Template and Version of the eSTAR
The eSTAR program has two templates, one for in vitro diagnostic devices and another for all other medical devices. The FDA issues regular updates, and you will want to check that your template is the most current version when you start and before you submit. For example, the FDA and Health Canada recently launched a joint pilot on using the eSTAR which triggered a change to the template to include both regulatory jurisdictions. Although you can open and view the templates in Adobe Acrobat Reader, you will need Adobe Acrobat Pro to save the submission when in progress, add attachments, and create the final PDF.
Read the eSTAR 510(k) guidance (and double-check for new FDA guidances)
On September 22, 2022, the FDA released the guidance ‘Electronic Submission Template for Medical Device 510(k) Submissions.’ The FDA is planning to release a similar De Novo submission guidance for using the eSTAR. The most useful item in the guidance is a table that provides an overview of the structure of the eSTAR, including a summary of the submission content to be provided in each section. It also includes hyperlinks to relevant guidances for sections such as Predicates and Substantial Equivalence and Labeling. Unfortunately, it is possible that the eSTAR 510(k) guidance will quickly become out-of-date as guidance documents are updated. One example is the FDA cybersecurity final guidance which is planned to be updated in 2023.
Keep confidential information out of the summary sections
The eSTAR template has several text boxes that must be filled in with a summary of information contained in the attachments of the submission (e.g., a summary of biocompatibility testing). There are several caution statements which warn the user not to enter confidential information. This would suggest they are considering semi-automating Freedom of Information Act (FOIA) requests by exporting the XML content of an eSTAR form but not the attachments. Therefore, an FOIA could consist of the XML export rather than manually creating a redacted 510(k) submission. While this could potentially speed up the receipt of an FOIA request, it may allow for confidential information to enter the public domain if you are not careful with your summary wording.
Store your attachments in an easily editable format
Once you convert your document into a PDF and attach it to the eSTAR form, it cannot be changed or modified. An attachment must be deleted, and a new PDF attached in its place. If you have multiple documents with similar content, it is best to combine them into one PDF and one upload per eSTAR section. Also be aware that the final size of the eSTAR PDF submission is 1 GB, and anything above that size may delay processing of the submission.
Register for a CDRH Portal (and remember to pay your fees!)
On October 3, 2022, the FDA announced that eSTAR can be submitted through the CDRH Customer Collaboration Portal (CDRH Portal). This builds on the progress tracker launched in 2021 for 510(k) submissions and allows anyone to register for a CDRH Portal account to send their eSTAR submissions online. Remember to pay the FDA user fees prior to your submission including registering for Small Business certification if your company is eligible. This is a key instruction on the eSTAR program page, template, and guidance.
The eSTAR program is the FDA’s current approach to implementing the electronic submission requirements in the amended FD&C Act. If the FDA continues to follow the list in the master guidance, a template for PMAs would be next.
The currently available templates provide an easy way for applicants to understand and plan for the regulatory requirements for their 510(k) or De Novo medical device submissions. Use this information to help guide your medical device design and development – download one today and try it out!
About the Author
Alexandra (Sandy) Reid is a QA/RA Specialist at StarFish Medical. She provides support to StarFish clients in the form of documentation generation, review and general quality and regulatory guidance for medical devices. She has a PhD in plant molecular biology, has filed several patents on manufacturing therapeutic proteins in plants, and was a reviewer for Canadian Federal natural sciences and engineering grant applications before joining StarFish.