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.
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
Original guidance
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