Monthly update
Regulatory update, October 2026: what changed in September
FDA confirms radiology AI software still needs a 510(k); the FY2027 FDA annual registration window opened on 1 October; EUDAMED registration for devices already on the EU market closes on 28 November.
Of September’s medical device regulatory news, three items matter most to manufacturers selling abroad: FDA formally confirmed that radiology AI software still requires a 510(k); the FY2027 FDA annual registration window opened on 1 October; and EUDAMED registration for devices already on the EU market closes on 28 November. Here are the key points.
1. FDA denies petition to exempt radiology AI software from 510(k)
- FDA denied the petition by letter on 1 April 2026, and formally confirmed the decision in a final order published in the Federal Register on 17 September (FR 2026-19074, Docket FDA-2025-P-5560), effective on publication.
- The petition asked for four types of imaging AI software to be exempt from 510(k) when certain conditions are met: 21 CFR 892.2060 (POK), 892.2070 (MYN), 892.2080 (QAS/QFM) and 892.2090 (QBS/QDQ).
- FDA found the petition did not show that safety and effectiveness could be reasonably assured without a 510(k), while restating its support for a least burdensome approach to regulating software.
Why it matters: Imaging AI is one of the most active routes into the US for Chinese manufacturers. Waiting for an exemption is no longer an option; 510(k) remains the main pathway. For ongoing product updates, plan with FDA’s final guidance on predetermined change control plans (PCCP) for AI-enabled software.
2. FY2027 annual registration: 1 October – 31 December
- FY2027 device user fees took effect on 1 October 2026 (FR 2026-15335, published 30 July). Establishment registration fee: $13,785. 510(k): $28,653 standard / $7,163 small business. De Novo: $191,020 / $47,755. PMA: $636,732 / $159,183.
- Registered establishments must complete annual registration between 1 October and 31 December, even if nothing has changed. Pay the fee first to obtain a PIN/PCN, then complete the registration.
- There is no small-business rate for the registration fee. A small business qualified through the SBD program that can show financial hardship may request a waiver of the annual registration fee (not for initial registration), at FDA’s discretion.
- Foreign establishments must designate one US Agent who lives or has a place of business in the US. The US Agent must reply to FDA’s confirmation email within 10 business days.
Why it matters: This is the most predictable deadline of the year, and the one most often left too late. An establishment that does not renew may be treated as unregistered, and its products risk being detained at import.
3. EUDAMED registration deadline of 28 November, and updated IVDR classification guidance
- The first four EUDAMED modules (Actor, UDI/Device, Notified Bodies & Certificates, Market Surveillance) have been mandatory since 28 May 2026.
- MDR/IVDR devices and legacy devices placed on the market before 28 May must be registered in EUDAMED by 28 November 2026 (European Commission note on transitional periods; Irish HPRA notice).
- September: MDCG 2020-16 rev.5 updates the guidance on IVDR classification rules.
- July: position paper MDCG 2026-5 makes clear that only the manufacturer may assign a UDI-DI. Devices sold under a distributor’s brand must also sit under the manufacturer’s name. A third party may do the data entry, but responsibility stays with the manufacturer.
Why it matters: Chinese OEM/ODM manufacturers often export to Europe under a distributor’s brand. UDI-DI assignment and EUDAMED data must be led by the manufacturer. The targeted MDR/IVDR amendments are still going through the legislative process; until they pass, current obligations are unchanged.
Other news this month
| Authority | Item | Key date |
|---|---|---|
| FDA | Draft guidance on premarket submissions for robotically assisted surgical devices (RASD) (FR 2026-19704) | Comments by 11/24 |
| FDA | Draft guidance on an electronic submission template (eSTAR) for PMA (FR 2026-19181) | Comments by 11/17 |
| FDA | CDRH launches the Regulatory Reliance Portal for other regulators | 9/14 |
| FDA | Information collection notice on Medical Device Tracking (FR 2026-18529) | Comments by 11/10 |
| FDA | Microbiology Devices Panel meeting: unbiased pathogen sequencing | 11/19 |
| FDA | CDRH FY2027 proposed guidance list (Docket FDA-2012-N-1021) | Comments by 11/30 |
| EU | MDCG 2020-16 rev.5: IVDR classification rules guidance | Published in September |
Key dates
| Date | Item |
|---|---|
| 11/10 | Comments close: FDA Medical Device Tracking information collection |
| 11/17 | Comments close: FDA PMA eSTAR draft guidance |
| 11/19 | FDA Microbiology Devices Panel meeting |
| 11/24 | Comments close: FDA RASD draft guidance |
| 11/28 | EUDAMED: registration deadline for devices on the market before 5/28 (mandatory) |
| 11/30 | Comments close: CDRH FY2027 guidance list |
| 12/31 | FDA FY2027 annual registration deadline (mandatory; pay the fee first) |
| Q1 2027 | European Parliament vote on targeted MDR/IVDR amendments (expected, per industry commentary) |
Sources
- Federal Register: FR 2026-19074 (final order on the imaging AI exemption petition), FR 2026-15335 (FY2027 device user fees), FR 2026-19704 (RASD draft guidance), FR 2026-19181 (PMA eSTAR draft guidance), FR 2026-18529 (Medical Device Tracking information collection)
- FDA: When to Register and List; U.S. Agents; MDUFA Fees; final guidance on PCCPs for AI-enabled device software; CDRH Regulatory Reliance Portal; CDRH FY2027 proposed guidance list; Microbiology Devices Panel meeting notice
- European Commission: EUDAMED overview and note on transitional periods; MDCG 2020-16 rev.5; MDCG 2026-5
- Irish HPRA: notice on mandatory use of EUDAMED modules
- The MDR/IVDR amendment timeline is industry commentary (Emergo by UL, 9 October 2026), for reference only
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First published on our WeChat official account ↗
This article is general information, not regulatory or legal advice for a specific device. Requirements change; check the official sources and the date above.