De Novo Classification Process for Novel Medical Devices Without Predicates
This guidance outlines the De Novo classification process, which provides a pathway to class I or class II classification for medical devices for which general controls or general and special controls provide reasonable assurance of safety and effectiveness, but for which there is no legally marketed predicate device.
What You Need to Know? 👇
What is the De Novo classification process and when should it be used?
The De Novo process provides a pathway to classify novel medical devices into Class I or II when no legally marketed predicate device exists. It’s used for devices automatically classified as Class III but where general controls or general and special controls can provide reasonable safety and effectiveness assurance.
Can I submit a De Novo request without first filing a 510(k)?
Yes, since FDASIA 2012, you can submit a “Direct De Novo” request without a preceding 510(k) if you determine there’s no legally marketed predicate device based on available information. This eliminates the previous requirement for an NSE determination first.
How long does FDA have to review a De Novo request?
FDA must make a classification determination within 120 calendar days of receiving an accepted De Novo request. The review clock may stop if additional information is requested or if the submission is placed on hold for deficiencies.
What happens if my De Novo request is granted?
If granted, your device is immediately classified as Class I or II and can be marketed subject to applicable controls. The device becomes a predicate for future 510(k) submissions, and FDA publishes a Federal Register notice within 30 days establishing the classification regulation.
Is a Pre-Submission meeting recommended before filing a De Novo request?
While not required, a Pre-Submission is strongly recommended, especially for devices FDA hasn’t previously reviewed. It provides early feedback on eligibility, potential predicate devices, required evidence, and likely regulatory controls needed for approval.
What are the main reasons a De Novo request gets declined?
Common reasons include: existence of a legally marketed predicate device, device falls under existing Class III regulation, insufficient data to demonstrate safety/effectiveness, or failure to show that general/special controls provide reasonable assurance of safety and effectiveness.
What You Need to Do 👇
Recommended Actions
- Conduct thorough search of FDA databases to confirm no predicate device exists
- Submit Pre-Submission to FDA to:
- Confirm De Novo eligibility
- Get feedback on required testing
- Review proposed controls and mitigations
- 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
- Submit valid eCopy of De Novo request
- Respond promptly to any FDA requests for additional information
- If granted, implement all required controls before marketing
- General controls for Class I
- General and special controls for Class II
- 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 đź”—
- 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 đź“‚
- 21 CFR Part 860: Medical Device Classification Procedures
- 21 CFR Part 820: Quality System Regulation