US FDA Announces De Novo Final Guidance and eSTAR Implementation Date

By Anna Flotilda Desales, Harrison Emery, and Sarah Fitzgerald

We last wrote about the U.S. FDA eSTAR when it became compulsory for 510(k)s. At the time, the eSTAR was voluntary for De Novos.

Background on De Novos

The De Novo Classification Request “De Novo” is the regulatory mechanism used when manufacturers have a novel medical device that they expect is not high risk and so should be Class II (special controls and general controls) or Class I (general controls). A De Novo is submitted when the manufacturer has determined there is no appropriate predicate device to claim substantial equivalence (SE) to or after a 510(K) was submitted with a verdict of not SE (NSE).

The FDA always recommends a Pre-Submission Q-submission for feedback before submitting a De Novo. In general, clinical evidence is necessary for the FDA to grant a De Novo, although there may be limited exceptions.

Completed reviews through the process are issued a “DEN” prefix and the device type is granted a product code and a specific classification (Class I or Class II). Subsequent devices can refer to that device as a predicate device and can be found SE to it through the 510(k) pathway.

Background on De Novos and eSTAR  

The use of the electronic Submission Template And Resource (eSTAR) for De Novos has been voluntary. The eSTAR is a dynamic PDF that includes logic and automation.

The U.S. FDA has required eSTAR for submission of 510(k)s since October 1, 2023.

FDA final rule and final guidance on De Novo electronic submissions

The FDA issued the Final Rule (FR Doc. 2024-18983) and  Final Guidance on the Electronic Submission Template for De Novo (FDA-2023-D-3788) on August 23, 2024.

The guidance was first issued as a draft September 29, 2023, which described the De Novo electronic format and technical standards but did not include a mandatory use date.

Within the final guidance, the FDA announced that eSTAR would be compulsory for De Novos, beginning October 1, 2025.

Concluding remarks

eSTAR use for De Novos will be the required submission format in about a year. This follows two years after the requirement to use eSTAR for 510(k)s was implemented.

While this is specific to the U.S. FDA, this also continues to advance the International Medical Device Regulators Forum (IMDRF) Regulated Product Submissions Working Group activities.  

We at Emergo are available to assist with global consulting and supporting you with the U.S. FDA eSTAR implementation for both 510(k)s and De Novos.