Electronic Submission Template And Resource (eSTAR) for 510k Submissions
This guidance describes the technical standards and requirements for preparing and submitting 510(k) premarket notifications electronically using FDA's electronic Submission Template And Resource (eSTAR). It establishes the format and standards for complying with section 745(A)(b)(3) of the FD&C Act which requires electronic submission of 510(k)s.
What You Need to Know? 👇
What is the FDA’s eSTAR template and how does it differ from the previous eSubmitter tool?
eSTAR (electronic Submission Template And Resource) is FDA’s current electronic submission template for 510(k)s, built within Adobe Acrobat Pro. Unlike the discontinued eSubmitter, eSTAR offers mobile compatibility, dynamic PDF features, supports supplements/amendments, and mirrors FDA’s internal review templates for more efficient processing.
When will electronic 510(k) submissions become mandatory and what are the requirements?
Electronic 510(k) submissions using eSTAR became mandatory on October 1, 2023. All traditional, special, and abbreviated 510(k)s must be submitted electronically through FDA’s portal (CDRH) or Electronic Submission Gateway (CBER). Paper submissions are no longer accepted after this date.
What types of 510(k) submissions are exempt from electronic submission requirements?
FDA exempts interactive review responses, appeals/supervisory review requests, substantive summary requests, change in correspondent amendments, post-decision add-to-files, and withdrawal requests from electronic submission requirements. These can still be submitted through traditional methods.
Will FDA grant waivers from the electronic submission requirements for 510(k)s?
No, FDA does not intend to grant waivers for 510(k) electronic submission requirements. Given the widespread availability of Adobe Acrobat Pro software needed for eSTAR and its free availability on FDA’s website, all submitters should have the capability to prepare electronic submissions.
What happens if my eSTAR submission fails FDA’s technical screening process?
If your eSTAR fails technical screening (conducted within 15 days), FDA will notify you via email identifying incomplete information. Your 510(k) will be placed on hold until a complete replacement eSTAR is submitted. If not corrected within 180 days, the submission will be withdrawn and closed.
Does using eSTAR eliminate the refuse-to-accept (RTA) process for 510(k) submissions?
Yes, properly prepared eSTAR submissions should represent complete submissions and are not anticipated to undergo the RTA process. The CDRH Portal automatically verifies eSTAR completeness, though FDA still employs virus scanning and technical screening to ensure accuracy and completeness of responses.
What You Need to Do 👇
Recommended Actions
- Download and familiarize with the eSTAR template from FDA’s website
- Ensure access to Adobe Acrobat Pro software to use eSTAR
- Review the structure and required content for each section of eSTAR
- Prepare all required testing data, documentation and attachments according to the template sections
- Complete all mandatory fields and questions in eSTAR to achieve “eSTAR Complete” status
- Submit via FDA’s electronic portal (CDRH) or Electronic Submission Gateway (CBER)
- Plan for electronic submission requirement by October 1, 2023
- Monitor FDA website for updates to eSTAR versions as policies change
- Ensure proper documentation for any exempt submissions that don’t require eSTAR
- Maintain compliance with eCopy requirements for exempt amendments
Key Considerations
Clinical testing
- Clinical study information must be included for in vitro diagnostic devices
- Clinical testing documents and applicable financial certifications/disclosure statements must be attached when clinical testing is used to support the submission
Non-clinical testing
- Performance testing information and test reports must be provided for determination of substantial equivalence
- For non-IVD devices: Non-clinical bench performance testing information required
- For IVD devices: Analytical performance, comparison studies, reference range/expected values required
Software
- Software documentation required if applicable
- Must follow guidance for content of premarket submissions for software contained in medical devices
Cybersecurity
- Assessment of cybersecurity required if applicable
- Must address interoperability considerations for interoperable medical devices
Labeling
- Proposed labeling must be submitted in sufficient detail per 21 CFR 807.87(e)
- For IVD devices, labeling must satisfy requirements of 21 CFR 809.10
- Must include device label, instructions for use, and patient labeling if applicable
Biocompatibility
- Biocompatibility assessment required for patient contacting materials
- Must follow ISO 10993-1 guidance for biological evaluation
Safety
- EMC, Electrical, Mechanical, Wireless and Thermal Safety testing required or justification why testing is not needed
- Risk analysis and control measures required for Special 510(k) submissions
Other considerations
- Must be submitted electronically via eSTAR starting October 1, 2023
- No RTA process for eSTAR submissions but will undergo technical screening within 15 days
- Must include administrative documentation like Truthful and Accuracy Statement and 510(k) Summary/Statement
- Certain amendments and interactive review responses are exempt from electronic submission requirements
Relevant Guidances 🔗
- Content of Premarket Submissions for Device Software Functions
- Cybersecurity in Medical Devices: Design, Implementation, and Premarket Submissions
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
Related references and norms 📂
- ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process