De Novo Classification
The De Novo classification pathway provides a route to market for novel medical devices that are low-to-moderate risk but have no legally marketed predicate device. Rather than defaulting to Class III (which would require PMA), De Novo allows these devices to be classified into Class I or Class II with general controls or special controls. Once granted, a De Novo device becomes a predicate for future 510(k) submissions.
Eligibility Criteria
A De Novo request is appropriate when all of the following conditions are met:
- The device is novel -- no legally marketed predicate device exists with the same intended use and technological characteristics
- The device is not high risk -- general controls alone, or general controls with special controls, provide reasonable assurance of safety and effectiveness
- The device would otherwise be automatically classified as Class III due to the absence of a predicate
A De Novo request can be submitted either directly (without a prior 510(k)) or after receiving a Not Substantially Equivalent (NSE) determination from a 510(k) review. Since the 21st Century Cures Act (2016), direct De Novo requests are permitted without first submitting a 510(k).
Reference: Section 513(f)(2) of the FD&C Act; 21 CFR 860.260
De Novo Submission Contents
A De Novo request should include the following elements per FDA guidance "De Novo Classification Process (Evaluation of Automatic Class III Designation)":
| Section | Description |
|---|---|
| Device Description | Complete description of the device, its components, intended use, and principles of operation |
| Proposed Classification | Recommended regulatory class (I or II), proposed product code, and classification panel |
| Proposed Special Controls | Specific special controls (if Class II) that mitigate identified risks; may include performance standards, post-market surveillance, labeling requirements, or design specifications |
| Risk Analysis | Identification of risks associated with the device and how general controls and/or proposed special controls mitigate each risk |
| Non-Clinical Testing | Performance testing, biocompatibility, electrical safety, EMC, software V&V, and other applicable bench and animal studies |
| Clinical Evidence | Clinical data or literature supporting safety and effectiveness (if applicable; not always required for low-risk devices) |
| Labeling | Proposed labeling, instructions for use, and any required warnings or contraindications |
Performance Criteria and Special Controls
When FDA grants a De Novo request and classifies the device into Class II, it establishes special controls that define the regulatory requirements for the new device type. These special controls become binding for the granted device and all future 510(k) submissions that use the De Novo device as a predicate. Common special controls include:
- Performance testing requirements: Specific bench tests, accuracy criteria, or pass/fail thresholds
- Clinical performance criteria: Sensitivity, specificity, or other clinical endpoints that must be met
- Labeling requirements: Mandatory warnings, contraindications, or training requirements
- Software validation: Software documentation level, cybersecurity requirements
- Biocompatibility testing: Specific ISO 10993 endpoints required
- Electromagnetic compatibility: IEC 60601-1-2 testing requirements
- Post-market surveillance: Required post-market studies or registries (less common)
When to Use De Novo vs. 510(k)
| Factor | 510(k) | De Novo |
|---|---|---|
| Predicate Device | Required -- must identify a legally marketed predicate | Not required -- for novel devices without a predicate |
| Risk Level | Low to moderate (Class I/II) | Low to moderate (results in Class I/II classification) |
| Review Timeline | 90 days (target) | 150 days (target); historically longer |
| Outcome | Clearance (substantially equivalent finding) | Classification order (creates new device type and product code) |
| User Fee (FY2024) | $22,550 (standard) | $0 (no user fee for De Novo requests) |
| Creates Predicate? | No (but the cleared device can be used as a predicate) | Yes -- establishes a new classification with special controls |
Post-Market Requirements
After a De Novo classification is granted, the device is subject to the same post-market requirements as other Class I or Class II devices:
- Medical Device Reporting (MDR) per 21 CFR 803 -- reporting of adverse events, malfunctions, and deaths
- Establishment registration and device listing per 21 CFR 807
- Quality System Regulation (21 CFR 820) compliance
- Corrections and removals reporting per 21 CFR 806
- Compliance with any specific special controls established in the De Novo classification order
- UDI requirements per 21 CFR 830 (compliance dates vary by device class)