FDA De Novo Classification Request

When does a device qualify for FDA De Novo?

A De Novo classification request asks the US FDA to classify a new device type into Class I or II when there is no legally marketed predicate and its risks can be adequately controlled. General controls may be sufficient for Class I; Class II also requires special controls. Novelty alone does not establish eligibility.

You can submit a direct De Novo request without first receiving a not-substantially-equivalent 510(k) decision. Alternatively, a request may follow an appropriate NSE determination. Avoid a speculative 510(k) merely to obtain that decision when the absence of a suitable predicate is already clear.

De Novo versus 510(k) and PMA

Use the classification guide to document product codes, regulations, intended use and available decisions. A device that cannot be adequately controlled as Class I or II may require PMA, not De Novo. A newly granted De Novo device can become a predicate for future 510(k) submissions where the rules are satisfied.

Build a risk-to-evidence and special-controls matrix

Define the device boundary first: hardware, accessories, software functions, users, patient population and use setting. Search FDA’s De Novo decisions and classification database for related device types and existing controls. Record why those classifications do or do not cover your device.

For each identified risk, document the cause, potential harm, proposed mitigation, verification or validation evidence, residual risk and proposed regulatory control. For example, an algorithm’s false-negative result may require performance testing in the claimed population, appropriate warnings and controls on updates. Labeling alone should not substitute for a feasible design control.

The submission commonly needs the device description, intended use, benefit-risk rationale, nonclinical testing, software and cybersecurity evidence where applicable, clinical/performance data where needed, labeling, and a justified proposal for classification and special controls. A clinical study is not automatically required for every De Novo, but the evidence must address the product’s actual risks and claims.

Use a Pre-Submission before costly evidence decisions

An FDA Pre-Submission is voluntary and can be useful before committing to a pivotal study, novel endpoint or unusual test method. Ask a focused question, give the proposed approach and explain the rationale. FDA feedback is not authorization and depends on the facts presented. Translate the feedback into controlled protocols and document later changes.

Fees, eSTAR and review time

For FY 2027, October 1, 2026–September 30, 2027, the FDA schedule lists a De Novo request fee of US$191,020, or US$47,755 for a qualified small business. Obtain the relevant determination before relying on a reduced fee. These are application fees, separate from testing, consulting and annual establishment registration.

De Novo requests have required eSTAR since October 1, 2025 unless exempted. Plan technical screening, substantive questions and applicant response work separately. FDA review-day goals do not equal the total calendar duration from concept to launch; study execution and response holds can be substantial.

What happens after a De Novo grant?

Read the classification order and final controls as binding conditions for the new device type. Update labeling and release records, implement any required controls, and ensure the marketed configuration matches the grant. Address establishment registration and listing, QMSR, UDI and Medical Device Reporting before and after supply.

Pure Global can assess pathway fit, organize the risk-to-evidence matrix, coordinate focused FDA questions and prepare the request. The launch plan should identify remaining gaps and owners rather than treating a grant as the end of lifecycle compliance.