De Novo Classification Request User Fees and Refund Policies
This guidance document outlines the user fee requirements and refund policies for De Novo classification requests submitted to FDA. It clarifies when user fees apply, exceptions to user fees, and circumstances under which refunds may be issued. The guidance also incorporates MDUFA V process improvements.
What You Need to Know? 👇
What are the current De Novo user fees under MDUFA V?
User fees for De Novo classification requests are established annually under section 738 of the FD&C Act. Current fees are published on the FDA MDUFA User Fees website and vary by fiscal year.
When can I get a refund for my De Novo user fee payment?
FDA will refund your fee if you qualify for statutory exceptions, fail to provide a valid eCopy/eSTAR before acceptance, your submission doesn’t meet acceptance criteria, or you withdraw an eSTAR that failed technical screening.
Do I need to pay additional fees for submitting more information to my pending De Novo request?
No additional fees are required when submitting supplemental information to a De Novo request that hasn’t received a final FDA decision. Only the original submission fee applies.
What happens if my De Novo request is declined - do I pay again for resubmission?
Yes, any new submission after a decline order requires payment of applicable fees. This includes new De Novo requests, 510(k)s, or PMAs, depending on your chosen pathway.
Are pediatric-only devices exempt from De Novo user fees?
Yes, De Novo requests for devices intended solely for pediatric populations are exempt from user fees under section 738(a)(2)(B)(v)(I) of the FD&C Act.
How do I request a user fee refund if I’m eligible?
Submit a written refund request to the appropriate FDA Center (CDRH or CBER) within 180 calendar days after the fee was due, using the addresses provided on their respective websites.
What You Need to Do 👇
Recommended Actions
- Determine if your De Novo request qualifies for a user fee exception
- Prepare user fee payment before submission using one of the approved methods:
- Credit card/electronic check (preferred)
- Paper check
- Wire transfer
- Ensure submission includes:
- Valid eCopy or eSTAR
- Payment Identification Number (PIN)
- User Fee Cover Sheet (Form FDA-3601)
- For eSTAR submissions:
- Monitor technical screening results within 15 days
- Be prepared to submit replacement if technical screening fails
- If seeking refund:
- Submit written request within 180 days of fee payment
- Include proper documentation to relevant FDA center
- Consider consulting FDA before submission through:
- Division of Industry and Consumer Education (DICE) for CDRH
- Manufacturers Assistance and Technical Training Branch (MATTB) for CBER
- 513(g) Request for Information if needed
Key Considerations
Software
- Electronic submissions using eSTAR must pass technical screening within 15 calendar days
- Failed eSTAR technical screening will result in submission being placed on hold until complete replacement is submitted
Other considerations
- Most De Novo requests require user fees except for:
- Devices intended solely for pediatric populations
- State/federal government entities for non-commercial devices
- User fees will be refunded if:
- A statutory exception applies
- Valid eCopy/eSTAR is not provided before acceptance
- Acceptance criteria are not met
- eSTAR fails technical screening and is withdrawn
- User fees will not be refunded if:
- De Novo request is accepted for review
- eSTAR passes technical screening
- De Novo request is declined
- New submissions after a decline require new user fees
Relevant Guidances 🔗
- De Novo Classification Process for Novel Medical Devices Without Predicates
- Electronic Submission Template And Resource (eSTAR) for De Novo Classification Requests
- De Novo Classification Request Review Process and Performance Goals
- Acceptance Review for De Novo Classification Requests
Related references and norms 📂
- 21 CFR 860.230: Procedures for accepting or refusing a De Novo request
- 21 CFR 860.250: Withdrawal of a De Novo request
- 21 CFR 860.260: Procedures for declining a De Novo request