Acceptance Review for De Novo Classification Requests
This guidance outlines the FDA's process and criteria for conducting acceptance reviews of De Novo classification requests. It provides recommendations on the types of information necessary for FDA to conduct a substantive review of a De Novo request and explains the acceptance review process. The guidance applies to De Novo requests submitted after the effective date of the final rule on De Novo Classification Process.
What You Need to Know? 👇
What is the purpose of the De Novo acceptance review process?
The acceptance review ensures De Novo requests contain necessary information for substantive review before FDA begins evaluation. This threshold determination helps focus Agency resources on complete submissions and provides more efficient device reviews.
How long does FDA have to complete the acceptance review?
FDA must complete the acceptance review within 15 calendar days of receiving the De Novo request. If not completed within this timeframe, the request is automatically accepted for substantive review.
What happens if my De Novo request receives a “Refuse to Accept” designation?
You’ll receive electronic notification identifying missing elements and a completed checklist. You have 180 days to submit the missing information without needing a new user fee or complete resubmission.
Can FDA request missing information during the acceptance review period?
Yes, FDA staff has discretion to request missing checklist items interactively during the 15-day review period, depending on available time and whether issues are appropriate for interactive resolution.
When does the FDA review clock start for De Novo requests?
The review clock starts on the DCC receipt date of the most recent submission that resulted in acceptance. It doesn’t start if the request is on user fee hold, eCopy hold, or designated RTA.
What’s the difference between acceptance review and substantive review?
Acceptance review only assesses whether required information is present, not its adequacy. Substantive review evaluates the quality and sufficiency of data to support device classification and marketing authorization.
What You Need to Do 👇
Recommended Actions
- Complete and submit the Acceptance Checklist with the De Novo request identifying location of supporting information
- Ensure all required administrative elements are included:
- Table of contents
- Page numbering
- Contact information
- Device description
- Prior submission information
- Provide comprehensive technical documentation:
- Performance data
- Test protocols and reports
- Software documentation if applicable
- Standards compliance information
- Include thorough clinical evidence if applicable:
- Study protocols
- Complete test reports
- Statistical analyses
- Compliance statements
- Submit complete labeling information:
- Device description
- Intended use
- Directions for use
- Required warnings/precautions
- Prepare detailed benefit-risk analysis and classification justification
- Address all applicable requirements for:
- Sterilization/reprocessing
- Biocompatibility
- Electrical safety
- Shelf life
- Ensure submission is for a single device type only
- Verify no open/pending submissions exist for same device
- Include financial disclosure information for clinical studies
Key Considerations
Clinical testing
- Must include study protocols and complete test reports for each clinical investigation
- Must provide number of investigators and subjects per investigator
- Must include investigation design, subject selection criteria, and study population details
- Must provide effectiveness and safety data, including adverse events
- Must include statistical analyses results
- Must include statements of compliance with GCP for OUS studies and 21 CFR parts 50, 56, and 812 for US studies
- Must provide financial disclosure information for clinical investigators
Non-clinical testing
- Must provide protocol and complete test report for each non-clinical study
- Must include test methods, acceptance criteria, and results
- Must provide appropriate performance testing based on device type
- Animal studies must include GLP compliance statement or justification for non-compliance
Software
- Must provide software level of concern and rationale
- Must include device hazard analysis, hardware and system information
- Must follow FDA guidance on software documentation or provide alternate approach with rationale
Labeling
- Must include labels, labeling and advertisements sufficient to describe the device
- Must provide directions for use
- Must include photographs or engineering drawings where applicable
- Must comply with 21 CFR parts 801 and 809 as applicable
Biocompatibility
- Must identify patient-contacting components and materials
- Must specify contact classification for each component
- Must provide biocompatibility assessment for patient-contacting components
Safety
- Must include electrical safety evaluation if applicable
- Must include electromagnetic compatibility testing if applicable
- Must provide sterilization validation if device is sterile
- Must include shelf life testing or rationale for why not needed
Other considerations
- Must provide device description including principles of operation
- Must include benefit-risk discussion
- Must identify proposed device class (I or II) and justify classification
- Must describe alternative practices and procedures
- Must provide classification summary for novel devices
- Must address standards compliance if standards are cited
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
- De Novo Classification Request User Fees and Refund Policies
- Content of Premarket Submissions for Device Software Functions
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
Related references and norms 📂
- IEC 60601-1: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances