Electronic Submission Template And Resource (eSTAR) for De Novo Classification Requests
This guidance describes the technical standards and requirements for electronic submission of De Novo classification requests using electronic submission templates, specifically the eSTAR (electronic Submission Template And Resource) template. It outlines the format requirements, implementation timeline, and criteria for waivers and exemptions under section 745A(b) of the FD&C Act.
Recommended Actions
- Download and use the eSTAR template from FDA’s website for De Novo submissions
- Ensure all required sections of the eSTAR template are completed:
- Device description and indications for use
- Classification proposal and justification
- Benefits/risks analysis
- Performance data
- Labeling
- Technical documentation
- Include all necessary attachments and supporting documentation
- Submit through appropriate electronic portal:
- CDRH submissions through FDA electronic portal
- CBER submissions through Electronic Submissions Gateway
- Plan for mandatory electronic submission requirement by October 1, 2025
- For questions:
- Contact OPEQSubmissionSupport@fda.hhs.gov for CDRH submissions
- Contact ESUBPREP@fda.hhs.gov for CBER submissions
- Note exemptions for certain types of submissions like interactive review responses and amendments
- Ensure submission is complete before submitting as incomplete submissions will be put on hold
Key Considerations
Software
- Software documentation must be submitted if applicable
- Documentation should follow FDA guidance for software content in medical device submissions
Cybersecurity
- Assessment of cybersecurity must be included if applicable
- Should address interoperability considerations for connected devices
Labeling
- Must include proposed labeling in sufficient detail
- For IVD devices, must satisfy requirements of 21 CFR 809.10
- Should include device label, instructions for use, and patient labeling
- For reprocessed devices, must include reprocessing validation and labeling
Biocompatibility
- Information on biocompatibility assessment required for patient-contacting materials
- Should follow ISO 10993-1 guidance
Safety
- EMC, Electrical, Mechanical, Wireless and Thermal Safety testing information required where applicable
- Testing documentation or justification for why testing is not needed must be provided
Other considerations
- Must include device description and proposed indications for use
- Classification summary and proposed class (I or II) must be provided
- Benefits, risks and mitigation measures must be detailed
- For Class II devices, proposed special controls must be specified
- Sterility and shelf life information required if applicable
- Administrative documentation and forms must be included
Relevant Guidances
- Content of Premarket Submissions for Device Software Functions
- Cybersecurity in Medical Devices: Design, Implementation, and Premarket Submissions
- De Novo Classification Process for Novel Medical Devices Without Predicates
- 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
- Electronic Submission Template And Resource (eSTAR) for De Novo Classification Requests
- HTML / PDF
- Issue date: 2024-08-23
- Last changed date: 2024-08-22
- Status: FINAL
- Official FDA topics: Medical Devices, Premarket, Electronic Submissions, Biologics
- ReguVirta summary file ID: c8c7b3d263f5f9e53153dd4ca2a6db42
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