[Home](/)/[Resources](/resources)/US De Novo Classification USFDA De Novo # US De Novo Classification The De Novo pathway provides a route for novel low to moderate risk medical devices without predicates. Understanding eligibility, submission requirements, and the classification process is essential for innovative devices. Copy Link[Share on WhatsApp](https://wa.me/?text=https%3A%2F%2Fkrono-labs.com%2Fguides%2Fus-de-novo-classification) At a glance Key concepts 4 Process steps 6 FAQs 5 ## Key concepts ### Novel Device A device that has no predicate and is of low to moderate risk. De Novo provides a pathway for these devices. ### Risk-Based Classification De Novo determines whether the device is Class I or Class II based on risk assessment. ### New Predicate Successful De Novo establishes a new classification and creates a predicate for future devices. ### Moderate Risk De Novo is only for devices of low to moderate risk. High-risk devices require PMA. ## Eligibility criteria No Predicate Device The device must be novel with no legally marketed predicate device. Low to Moderate Risk The device must pose low to moderate risk to patients. High-risk devices require PMA. Not Exempt The device must not be exempt from premarket notification under 510(k) exemptions. First of Its Kind The device represents a new technology or intended use not previously marketed. ## Submission requirements Device Description Detailed description of the device including design, materials, and principles of operation. Intended Use and Indications Clear statement of intended use and indications for use. Risk Assessment Comprehensive risk assessment identifying potential risks and mitigation strategies. Performance Data Data demonstrating safety and effectiveness, which may include clinical data depending on device type. Labeling Proposed labeling including instructions for use, warnings, and contraindications. ## Process steps 01 Pre-Submission Meeting Meet with FDA to discuss device characteristics and appropriate data requirements. 02 Submission Preparation Prepare De Novo submission with required data and documentation. 03 Submission Submit De Novo request through FDA's electronic submission system with required fee. 04 FDA Review FDA reviews submission for safety and effectiveness. May request additional information. 05 Classification Decision FDA issues classification decision (Class I or Class II) and approval or denial. 06 Post-Market If approved, device can be marketed. Post-market requirements may apply. ## Common compliance mistakes Using De Novo for high-risk devices - De Novo is only for low to moderate risk Not demonstrating novelty - must truly have no predicate device Inadequate risk assessment - comprehensive risk assessment is required Insufficient performance data - must provide data demonstrating safety and effectiveness Not considering clinical data - some devices require clinical studies Underestimating complexity - De Novo is more complex than 510(k) but less than PMA ## Frequently asked questions ### When should I use the De Novo pathway? Use De Novo when your device is novel (no predicate), poses low to moderate risk, and is not exempt from premarket notification. De Novo is ideal for innovative devices that don't fit existing classifications but aren't high-risk enough for PMA. ### How does De Novo differ from 510(k) and PMA? 510(k) requires a predicate device. PMA is for high-risk devices requiring clinical data. De Novo is for novel low to moderate risk devices without predicates. De Novo is more rigorous than 510(k) but less than PMA. ### How long does the De Novo process take? FDA's target review time is 120 days for De Novo. However, including preparation, potential additional information requests, and review, the total timeline typically ranges from 6-12 months. Pre-submission meetings can help streamline the process. ### What data is required for De Novo? Data requirements depend on device type and risk. May include bench testing, animal studies, or clinical data. The goal is to demonstrate safety and effectiveness. Risk assessment and performance data are always required. ### What happens after successful De Novo? Successful De Novo establishes a new classification (Class I or Class II) and creates a predicate for future devices. Future devices can use your device as a predicate for 510(k) submissions. This is a significant advantage. **Disclaimer:** This guide provides general information about De Novo requirements. Device-specific determinations require analysis of FDA regulations. Always verify current requirements with FDA resources or qualified regulatory professionals. πŸ‡ΊπŸ‡Έ US roadmap for your product Every standard, document, and test that applies β€” free, no account required. See your free roadmap[ Want an expert to take your product through πŸ‡ΊπŸ‡Έ US compliance for you? One consultant from Krono's compliance team takes your product from requirements to legal sale, with a fixed quote before any work starts. See compliance services](/services) Related guides * [FDA Medical Device RegulationComplete guide to FDA medical device regulation.](/guides/fda-medical-device-regulation) * [US Medical Devices ClassificationComplete guide to US medical devices classification.](/guides/us-medical-devices-classification) * [US 510(k) Premarket NotificationComplete guide to US 510(k) premarket notification.](/guides/us-510k-premarket-notification) * [US PMA Premarket ApprovalComplete guide to US PMA premarket approval.](/guides/us-pma-premarket-approval)