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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.

  1. Ensure user fee payment and valid eCopy/eSTAR submission before filing
  2. Follow the acceptance review checklist to ensure submission completeness
  3. Implement quality system to ensure compliance with:
    • Clinical investigation requirements
    • Non-clinical study requirements
    • Labeling requirements
  4. Plan for interactive review process to efficiently resolve deficiencies
  5. 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
  6. Maintain documentation of compliance with all applicable regulations
  7. Consider requesting discussion with FDA if decision not reached within 180 FDA days
  8. Ensure facilities are prepared for potential FDA inspections
  9. 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

  • 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

Original guidance

  • De Novo Classification Request Review Process and Performance Goals
  • HTML / PDF
  • Issue date: 2022-10-03
  • Last changed date: 2022-10-03
  • Status: FINAL
  • Official FDA topics: Medical Devices, Administrative / Procedural, Premarket
  • ReguVirta summary file ID: c2f4698659f9c6ef6f8f9960dd06f7ba
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