De Novo Requests
What Is a De Novo Classification Request?
The De Novo classification request offers a pathway for categorizing innovative medical devices that lack a legally marketed predicate device but demonstrate reasonable safety and effectiveness for their intended use. This pathway involves a risk-based classification approach.
Devices classified under class I or class II via a De Novo request can serve as predicates for future premarket notification (510(k)) submissions, when applicable.
Regulations and Criteria for De Novo Classification Requests
The FDA has established new regulations, as per a final rule, to implement the medical device De Novo classification process under the FD&C Act. This rule outlines criteria for De Novo classification requests, covering aspects such as the format and content of these requests, along with procedures and standards for accepting, approving, rejecting, and retracting De Novo requests.
When and How to Prepare a De Novo Request?
There are two pathways available for submitting a De Novo request to the FDA, allowing for a risk-based evaluation to classify the device as either class I or II.
- Option 1: Submitting a De Novo request after receiving a high-level determination of not substantially equivalent (NSE) following a 510(k) submission.
- Option 2: Submitting a De Novo request directly without first submitting a 510(k) and receiving a high-level NSE determination.
Prior to submitting a De Novo request to the FDA, it is recommended that sponsors consider submitting a Pre-Submission to seek feedback from the relevant premarket review division.
How to Submit a De Novo Request
- Online: Send eSTAR or eCopy premarket submissions online through the CDRH Customer Collaboration Portal (CDRH Portal).
- By Mail: De Novo requests should be submitted in an electronic format (eCopy) to the FDA.
Content of the De Novo Request
The content of a De Novo Request should include administrative information, device description, classification information, supporting data, and a description of the device’s benefits compared to risks.
FDA Review & Timeline
The FDA’s review process and timeline for De Novo requests involve several stages:
- Acceptance Review
- Substantive Review
- Response Submission
- De Novo Request Decision
What are the FDA Final Actions on a De Novo Request?
The FDA’s final actions on a De Novo request can result in three possible outcomes: Grant, Decline, or Withdrawal. Each outcome has specific implications for the device’s classification and marketing authorization.
About Accel
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