De Novo Classification Process for Novel Medical Devices Without Predicates

Recommended Actions

1. Conduct thorough search of FDA databases to confirm no predicate device exists
2. Submit Pre-Submission to FDA to:
   • Confirm De Novo eligibility
   • Get feedback on required testing
   • Review proposed controls and mitigations
3. Prepare comprehensive De Novo submission including:
   • Device description and intended use
   • Risk analysis and mitigations
   • Test protocols and data
   • Proposed controls
   • Valid scientific evidence supporting classification
4. Submit valid eCopy of De Novo request
5. Respond promptly to any FDA requests for additional information
6. If granted, implement all required controls before marketing
   • General controls for Class I
   • General and special controls for Class II
7. If declined:
   • Submit PMA application, or
   • Address issues and submit new De Novo request

Key Considerations

Clinical testing

• Clinical data may be required to support the De Novo request
• Study design and control group selection should be appropriate if clinical data is needed
• Valid scientific evidence must demonstrate probable benefits outweigh probable risks

Non-clinical testing

• Non-clinical study protocols must allow collection of data to demonstrate device safety and effectiveness
• Test methods and protocols should be reviewed with FDA prior to conducting studies
• Valid scientific evidence from non-clinical testing required to support classification

Software

• Software level of concern must be identified and appropriate for the device
• Software documentation requirements based on level of concern

Labelling

• Labeling requirements must be identified as part of special controls for Class II devices
• Proposed mitigation measures/controls must be detailed in labeling

Biocompatibility

• Appropriate biocompatibility testing must be conducted based on device characteristics
• Sterility testing requirements must be identified if applicable

Safety

• All probable risks to health must be identified and explained
• Proposed mitigation measures/controls for each risk must be detailed
• Risk analysis must demonstrate general or general and special controls provide reasonable assurance of safety

Other considerations

• Device description and intended use must be clearly defined
• Search of FDA databases required to confirm no predicate exists
• Pre-submission recommended but not required
• 120-day review timeline for FDA decision
• Valid eCopy submission required
• Device remains Class III if De Novo request declined

  Relevant Guidances

• Content of Premarket Submissions for Device Software Functions
• Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
• 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
• Benefit-Risk Determinations for Medical Device Premarket Review

Related references and norms

• 21 CFR Part 860: Medical Device Classification Procedures
• 21 CFR Part 820: Quality System Regulation

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Original guidance

• De Novo Classification Process for Novel Medical Devices Without Predicates
• HTML / PDF
• Issue date: 2021-10-05
• Last changed date: 2022-02-18
• Status: FINAL
• Official FDA topics: Medical Devices, Administrative / Procedural, Premarket, Biologics
• ReguVirta summary file ID: cbcec12b26d5d720ff208787a6ad0367