Electronic Submission Standards for Pre-Submissions Using eSTAR Template System (DRAFT)
This guidance describes the technical standards for preparing electronic submission templates for Q-Submissions (Q-Subs) that enable submission solely in electronic format. Currently, Pre-Submissions (Pre-Subs) are the only type of Q-Sub available for electronic submission through the eSTAR (electronic Submission Template And Resource) system. The guidance establishes electronic format standards for complying with section 745(A)(b)(3) of the FD&C Act and will be updated as other Q-Sub types are implemented within the eSTAR program.
This is a draft guidance. Not for implementation.
What You Need to Know? 👇
What is the FDA’s eSTAR electronic submission template for medical devices?
eSTAR (electronic Submission Template And Resource) is a structured dynamic PDF that guides users through constructing complete Q-Submissions, particularly Pre-Submissions. It includes automated features, integrated databases, targeted questions, and links to relevant regulations and guidance documents for medical device submissions.
When will electronic submissions become mandatory for Pre-Submissions?
Electronic submissions for Pre-Submissions will be required starting one year after the final guidance is issued. Currently, eSTAR use is voluntary during the transition period. The implementation follows FDA’s mandate under section 745A(b) of the FD&C Act.
What types of Pre-Submission content are exempt from electronic submission requirements?
Exemptions include interactive review responses, certain amendments, appeals/supervisory review requests, change in correspondent/legal entity, amendments after decision, meeting minutes, meeting minutes disagreements, presentation slides, and withdrawal requests. These can still be submitted through traditional methods.
How does FDA’s technical screening process work for eSTAR submissions?
FDA conducts technical screening within 15 calendar days to verify eSTAR responses accurately describe devices and include required attachments. If screening fails, FDA notifies submitters via email. Submissions remain on hold until additional information is provided within 180 days.
What are the key structural components of the current Pre-Sub eSTAR template?
The template includes submission type identification, cover letter section, applicant information, previous regulatory interactions, consensus standards, submission characteristics, product description, device uses/indications, classification, labeling, references, Pre-Sub questions, and amendment/additional information responses.
Can submitters request waivers from electronic submission requirements for Pre-Submissions?
Currently, FDA has not identified circumstances appropriate for waivers and does not intend to grant waiver requests. Given widespread software availability for eSTAR PDF use, all submitters should have the ability to provide Pre-Sub eSTARs electronically.
What You Need to Do 👇
Recommended Actions
- Begin familiarizing teams with the eSTAR electronic submission template system for Pre-Submissions
- Download and review the current PreSTAR template from FDA’s website to understand submission requirements
- Establish internal processes for preparing electronic submissions using the structured format outlined in Table 1
- Ensure technical capabilities are in place to submit through FDA’s electronic portals (CDRH Portal or CBER Electronic Submissions Gateway)
- Plan for the transition period (minimum one year from final guidance) to mandatory electronic submissions
- Train submission teams on the technical screening process and requirements to avoid submission holds
- Review current Pre-Sub preparation processes against the eSTAR template structure to identify gaps
- Consider voluntary use of eSTAR during the transition period to gain experience with the system
- Establish contact with appropriate FDA support emails for submission preparation questions (OPEQSubmissionSupport@fda.hhs.gov for CDRH, ESUBPREP@fda.hhs.gov for CBER)
Key Considerations
Labelling
- Proposed labeling must be submitted in sufficient detail to describe the product, its intended use, and directions for use
- Labeling includes device label, instructions for use, and any patient labeling
- Updated draft labeling should be included in the Labeling section of eSTAR when submitting amendments
Software
- eSTAR is built within a structured dynamic PDF format
- Electronic submissions must be submitted using FDA’s electronic portal for CDRH submissions
- For CBER submissions, use the Electronic Submissions Gateway
- Virus scanning and technical screening processes will be employed for eSTAR submissions
Other considerations
- Electronic submissions properly prepared with eSTAR should represent a complete submission and are not anticipated to undergo refuse to accept (RTA) process
- Technical screening process will verify eSTAR responses accurately describe devices within 15 calendar days
- If technical screening fails, submissions will be placed on hold until additional information is submitted within 180 days
- Minimum one-year transition period will be provided from final guidance issuance before requiring all Pre-Subs as electronic submissions
- Specific exemptions apply including interactive review responses, certain amendments, appeals, meeting minutes, and withdrawal requests
- No waivers are anticipated to be granted given widespread software availability
Relevant Guidances 🔗
- Q-Submission Program: Strategic Framework for FDA Interactions in Medical Device Development
- Electronic Submission Template And Resource (eSTAR) for 510k Submissions
- Electronic Submission Template And Resource (eSTAR) for De Novo Classification Requests
- Electronic Copy (eCopy) Program for Medical Device Submissions: Technical Standards and Requirements
- Electronic Submission Requirements for Medical Device Submissions