De Novo Classification Request Review Process and Performance Goals
This guidance describes the different FDA actions and industry actions that may be taken on De Novo classification requests, as well as their effects on review goals under MDUFA IV (FY 2018-2022) and MDUFA V (FY 2023-2027). It covers the FDA review process, timelines, and performance goals for De Novo requests.
What You Need to Know? 👇
What are the key FDA actions that can be taken on a De Novo classification request?
FDA can issue a granting order (approving classification into Class I or II), a decline order (keeping device in Class III), request additional information (AI request), or issue a notice of withdrawal if requirements aren’t met within specified timeframes.
How do MDUFA V performance goals differ from MDUFA IV for De Novo requests?
MDUFA V maintains the 150 FDA day review timeline but introduces escalating performance goals: 70% in FY 2023-2025, potentially increasing to 80% in FY 2026 and 90% in FY 2027 if earlier goals are met.
What happens to the review clock when FDA issues an AI request?
An AI request stops the review clock and places the submission on hold. The clock resumes only when FDA receives a complete response addressing all identified deficiencies within 180 calendar days of the original AI request.
What are the main grounds for FDA to decline a De Novo classification request?
FDA can decline if the device doesn’t meet Class I/II criteria, contains false statements, has labeling issues, is already classified, has inadequate clinical data, or involves significant unsolicited changes after acceptance for review.
What electronic submission requirements apply to De Novo requests under MDUFA V?
All De Novo requests must include user fee payment confirmation and either a valid eCopy or eSubmission using eSTAR template. Submissions won’t be processed without these requirements being met for distribution to review offices.
What constitutes a complete response to an FDA additional information request?
A complete response must address all deficiencies identified in FDA’s AI request. If any deficiencies remain unaddressed, FDA will place the submission back on hold, and the 180-day response deadline continues from the original AI request date.
What You Need to Do 👇
Recommended Actions
- Ensure user fee payment and valid eCopy/eSTAR submission before filing
- Follow the acceptance review checklist to ensure submission completeness
- Implement quality system to ensure compliance with:
- Clinical investigation requirements
- Non-clinical study requirements
- Labeling requirements
- Plan for interactive review process to efficiently resolve deficiencies
- Track review timelines and respond promptly to FDA requests:
- 15 days for acceptance review
- 180 days maximum to respond to additional information requests
- 150 FDA days target for final decision
- Maintain documentation of compliance with all applicable regulations
- Consider requesting discussion with FDA if decision not reached within 180 FDA days
- Ensure facilities are prepared for potential FDA inspections
- Monitor submission status and maintain active communication with FDA throughout review process
Key Considerations
Clinical testing
- Clinical investigations involving human subjects must comply with IRB regulations (21 CFR part 56), informed consent regulations (21 CFR part 50), and GCP (21 CFR 812.28(a))
- Clinical studies must be completed per protocol and adequately address any deficiencies identified
Non-clinical testing
- Nonclinical studies subject to 21 CFR part 58 must be conducted in compliance with these regulations
- Any non-compliance must be justified and the practices used must support study validity
Labeling
- Device labeling must comply with requirements in 21 CFR parts 801 or 809 as applicable
Safety
- General controls or general and special controls must provide reasonable assurance of safety and effectiveness
- Facility inspections must support that controls provide reasonable assurance of safety and effectiveness
Other considerations
- Submissions require user fee payment and valid eCopy/eSTAR
- 15-day acceptance review timeline
- 150 FDA days review goal with performance targets increasing from 70% to potentially 90% by FY2027
- Interactive review process available for resolving deficiencies
- Withdrawal occurs if no response within 180 days of additional information request
Relevant Guidances 🔗
- De Novo Classification Process for Novel Medical Devices Without Predicates
- Refuse to Accept Policy for 510k Submissions: Minimum Threshold Requirements for Administrative and Technical Review
- Electronic Copy (eCopy) Program for Medical Device Submissions: Technical Standards and Requirements
- Electronic Submission Template And Resource (eSTAR) for De Novo Classification Requests
- De Novo Classification Request User Fees and Refund Policies
Related references and norms 📂
- 21 CFR Part 58: Good Laboratory Practice for Nonclinical Laboratory Studies
- 21 CFR Part 50: Protection of Human Subjects
- 21 CFR Part 56: Institutional Review Boards
- 21 CFR Part 801: Labeling
- 21 CFR Part 809: In Vitro Diagnostic Products for Human Use
- 21 CFR Part 860: Medical Device Classification Procedures