The Monthly Take: October 2026
Once a month I pull together the FDA moves that actually matter if you're building a medical device. Here's October.
1. Registration renewal is open
FY2027 establishment registration runs October 1 to December 31, and the annual fee is now $13,785. Foreign firms: check that your U.S. Agent information is still correct before you renew.
2. New user fees kicked in October 1
A standard 510(k) is now $28,653, or $7,163 for a small business. Get your small business determination done before you submit. It's a 75% discount, and it doesn't apply after the fact.
3. Generative AI comments close October 19
FDA wants input on how it should evaluate devices that use generative AI (docket FDA-2026-N-7874). If your product uses it, this is your chance to weigh in.
4. No 510(k) exemption for radiology AI
FDA denied the petition to exempt CADe, CADx and triage software (final order September 17). If you're building one of these, plan for a 510(k).
5. eSTAR is coming for PMAs
Draft guidance came out September 17. Also new: draft guidance on robotically-assisted surgical devices, with a public workshop on December 2.
What to watch in November
- CDRH FY2027 proposed guidance list. Comments are open through November 30 (FDA-2012-N-1021).
- EU EUDAMED device registration deadline: November 28.
Not sure how any of this affects your device? Book a free 30-minute call and we'll talk it through.
Trey Thorsen, O'Connell & Myers, LLC. 20 years in medical device regulatory affairs.