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.
What You Need to Know? 👇
What is the mandatory implementation date for De Novo electronic submissions using eSTAR?
October 1, 2025 is the mandatory implementation date for De Novo electronic submissions. After this date, all De Novo requests must be submitted using the eSTAR electronic submission template, with limited exemptions for specific submission types like interactive review responses and appeals.
Which submissions are exempt from the De Novo electronic submission requirements?
Interactive review responses, amendments, appeals/supervisory review requests, substantive summary requests, change in correspondent amendments, amendments after final decision (add-to-files), and withdrawal requests are exempt from the electronic submission requirements and can continue using traditional submission methods.
How long does FDA have to complete technical screening for De Novo eSTAR submissions?
FDA must complete technical screening within 15 calendar days of receiving a De Novo eSTAR submission. If technical screening is not completed within this timeframe, FDA will automatically accept the De Novo request for review and notify the requester.
What happens if my eSTAR submission is incomplete during technical screening?
FDA will notify you via email identifying the incomplete information, and your De Novo will be placed on hold. You have 180 days from the technical screening deficiency notification to submit a replacement eSTAR, or FDA will consider the submission withdrawn and close it.
Can I voluntarily use eSTAR for De Novo submissions before the mandatory date?
Yes, eSTAR is available for voluntary use during the transition period leading up to October 1, 2025. CDRH made the De Novo eSTAR template available in January 2022, allowing submitters to familiarize themselves with the electronic format before it becomes mandatory.
What are the key benefits of using the eSTAR template for De Novo submissions?
eSTAR provides guided prompts, integrated databases (FDA product codes, recognized standards), automated acceptance review processes, and structured data collection that closely follows FDA’s review memo template. This enhances submission consistency, quality, and review efficiency while reducing preparation time.
What You Need to Do 👇
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