This content is only available to our Premium subscribers. See our Subscribe page for information on subscriptions.
The agency rule list for Spring 2020, accessible at https://www.reginfo.gov/public, announced that the “Medical Device De Novo Classification Process” rule is in the final rule stage. Although the FDA has previously written a guidance document about the De Novo process, they are taking the more formal step of agency rule-making regarding the topic as well. The abstract says the upcoming final rule “would establish procedures and criteria for the De Novo process and would make it more transparent and predictable for manufacturers.”
The FDA initially proposed this rule on the De Novo process in December 2018 – read the proposed rule in the Federal Register here: Proposed De Novo Rule. In the proposed rule, the FDA sought to “establish requirements for the medical device De Novo classification process under the Federal Food, Drug, and Cosmetic Act.” The purpose of the proposed rule was consistent with what is already understood about the De Novo classification process:
- A manufacturer may submit a De Novo request after receiving a NSE determination in response to a 510(k) submission, or
- A manufacturer may submit a De Novo request as their first submission because they have determined there is no substantially equivalent device.
In Latin, the phrase “de novo” means “from the new” – so, it makes sense that De Novo requests allow the FDA to classify novel devices as Class I or II. Then, subsequent submissions for a device of the same type may rely on the De Novo determination as a predicate device for a substantial equivalence decision.
The December 2018 proposed rule suggested a more standardized process for De Novo requests – requiring the submission of “administrative information, regulatory history, device description [including intended use], classification summary information, benefits and risks of device use, and performance data to demonstrate reasonable assurance of safety and effectiveness.” It seems that when this rule becomes final (likely sometime soon, as it is in the final stages of rulemaking), there will be a clear format for the document that device manufacturers need to submit to the FDA if they want to receive De Novo classification. We will be sure to update our readers when the rule is final. We expect to see an Appendix which details what these more formal De Novo requests should look like for a regulatory submission to the FDA.