FDA Compliance
De Novo Classification
The De Novo Classification pathway is an FDA route designed for novel
Applies to: Manufacturers of novel devices without a predicate
What Is De Novo Classification and Why It Matters?
The De Novo Classification pathway is an FDA route designed for novel, low-to-moderate risk medical devices that have no legally marketed predicate device and therefore cannot follow the 510(k) pathway. Rather than being automatically classified as Class III and subjected to the full PMA process, manufacturers can request a risk-based classification review through De Novo. If granted, the FDA classifies the device as Class I or Class II and may establish special controls to ensure its safety and effectiveness. A successful De Novo request not only brings your device to market but also establishes it as a predicate device, allowing future similar devices to follow the 510(k) pathway. The process requires a thorough and well-structured submission, and any gaps in the safety and effectiveness evidence can result in a denial or a request for additional information.
How Can We Help?
At Certilance, we guide you through the De Novo process with a clear and methodical approach. From assessing whether De Novo is the right pathway for your device, to defining the appropriate device classification and proposed special controls, our consultants build a submission that is structured to meet FDA expectations. We support you through every stage of the FDA review process to maximize your chances of a successful classification decision.
FAQ
De Novo — frequently asked questions
Yes. Medical devices must obtain FDA clearance or approval before being marketed in the United States. The pathway depends on device classification, intended use, and risk profile.
The U.S. Food and Drug Administration (FDA) regulates devices through:
- 510(k) premarket notification
- De Novo classification
- Premarket Approval (PMA)
Each pathway has different evidence, testing, and review requirements.
No. CE marking and FDA approval are completely separate regulatory systems. Compliance with one does not grant access to the other market.
FDA does not formally certify ISO standards. However, an ISO 13485-aligned quality system strongly supports FDA Quality System Regulation (QSR) compliance and significantly reduces inspection findings.
Certilance helps manufacturers prepare documentation, quality systems, and regulatory evidence aligned with FDA expectations, ensuring submissions and inspections proceed efficiently.
FDA timelines vary by pathway (510(k), De Novo, or PMA) and submission quality. While FDA review periods are defined, real-world timelines are often extended due to deficiency letters, additional data requests, or design control gaps.
Early regulatory alignment significantly reduces delays.
FDA-related costs depend on:
- Regulatory pathway
- Testing and validation requirements
- Submission complexity
- FDA user fees (where applicable)
Well-structured submissions reduce review cycles and overall cost exposure.
FDA Compliance
Related services
De Novo
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