eSTAR becomes mandatory for De Novo requests on October 1

De Novo requests reaching FDA from October 1, 2025 must use eSTAR, the agency's structured PDF template, and arrive through the CDRH Customer Collaboration Portal. Mailed De Novos count only if FDA received them before that date. The requirement comes from the final guidance issued August 23, 2024 under Docket FDA-2023-D-3788. Waivers and exemptions exist and sit in Section VI.A of that guidance.

The mechanics affect timing. FDA runs a technical screening on the eSTAR in place of a refuse-to-accept review. A request that passes counts as received on the day it was uploaded, and the 150-day MDUFA clock runs from there. One that fails waits on hold until a complete version arrives. The FY2026 De Novo fee is $173,782, or $43,446 with an approved small business determination.

The template also enforces a useful discipline. Every eSTAR section maps to a guidance, so a De Novo built inside the template exposes gaps in software documentation, cybersecurity or biocompatibility before a reviewer finds them. Teams that draft in Word and paste at the end tend to discover the mismatch during the screening hold.

Questions & Answers

When did eSTAR become mandatory for FDA De Novo requests?

FDA began requiring eSTAR for De Novo classification requests on October 1, 2025, under the final guidance Electronic Submission Template for Medical Device De Novo Requests issued August 23, 2024 (Docket FDA-2023-D-3788).

How much is the FDA De Novo user fee in fiscal year 2026?

The FY2026 De Novo fee is $173,782 for a standard applicant and $43,446 for a company with an approved small business determination.

Can a De Novo request still be mailed to FDA after October 1, 2025?

No. FDA accepts mailed De Novo requests only if it received them before October 1, 2025. Later requests must be eSTAR submissions uploaded through the CDRH Portal unless a waiver or exemption applies.

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