The week of 28 September–4 October 2026 brought several relevant regulatory updates in the medical device and in vitro diagnostic (IVD) sectors.
This edition covers FDA’s proposed FY2027 guidance priorities, new swissdamed functionality for importers, Australia’s medical device software and AI reform programme, a first-of-its-kind FDA approval for a pediatric heart valve, and an independent assessment of MDUFA V.
In this issue
- FDA publishes CDRH proposed FY2027 guidance priorities
- Swissmedic makes swissdamed importer-linking function available
- TGA updates medical device software and AI reform programme
- FDA approves first heart valve designed to grow with children
- FDA publishes MDUFA V Independent Assessment
FDA Publishes CDRH Proposed FY2027 Guidance Priorities
On 1 October 2026, FDA’s Center for Devices and Radiological Health published its proposed guidance priorities for fiscal year 2027.
The A-list identifies priority guidance documents that CDRH intends to publish during FY2027.
Topics include final guidance on marketing submissions and lifecycle management for AI-enabled device software functions, Predetermined Change Control Plans, quality management system information for certain premarket application reviews and the ASCA Program.
The A-list also includes a planned draft guidance on evidentiary recommendations for generative AI-enabled conversational devices for mental disorders.
The B-list includes a proposed draft guidance on postmarket management of cybersecurity in medical devices.
“Under Construction” list includes work on risk and evidentiary considerations for generative AI-enabled devices and selected 510(k) topics.
FDA is accepting comments on the guidance priorities until 30 November 2026.
The lists provide an early view of CDRH’s planned policy work for FY2027, with AI, software lifecycle management and cybersecurity among the recurring themes.
Source: FDA
Reference: CDRH Proposed Guidances for Fiscal Year 2027, FY 2027, FDA
Swissmedic Makes swissdamed Importer-Linking Function Available
On 1 October 2026, Swissmedic made available the technical functionality allowing importers to link themselves to medical devices already registered in swissdamed.
The linkage is based on the UDI-DI.
Importers do not register devices themselves. Instead, they link their actor registration to UDI-DIs already registered in swissdamed by the authorised representative, foreign manufacturer or foreign person who assembles systems or procedure packs.
Swissmedic has established a transitional period until 1 April 2027.
Until that date, the authority states that it will not take enforcement measures solely because a required importer-device link is missing.
From 1 April 2027, delays between placing an imported device on the Swiss market and completing the linkage will no longer be accepted.
The new functionality adds an operational component to the mandatory swissdamed device-registration framework introduced earlier in 2026.
Read the dedicated insight: Swissdamed: Importer Linking to Registered Devices Now Available
Source: Swissmedic
Reference: Importers — Obligations of Importers in swissdamed, Swissmedic
TGA Updates Medical Device Software and AI Reform Programme
On 30 September 2026, Australia’s Therapeutic Goods Administration updated its medical device software reform programme with new information on the outcomes of its AI review and the projects now being taken forward.
The review concluded that the existing regulation of software and AI remains broadly appropriate.
At the same time, TGA identified five areas for further work: stakeholder support, robust regulation, roles and responsibilities, transparency of AI use and compliance activities.
TGA states that current work includes reviewing regulatory definitions, improving visibility of AI-enabled products and undertaking targeted compliance activities.
The programme also includes a review of the regulatory exclusion for certain digital mental health tools.
It also includes work on digital or AI scribes to clarify when these products meet the definition of a medical device.
TGA states that the outcomes of its digital scribes review will be published separately.
The update provides a current view of how TGA is developing its regulatory approach to software and AI following its broader review of the existing framework.
Source: Therapeutic Goods Administration
Reference: Medical devices reforms: software regulation, TGA
FDA Approves First Heart Valve Designed to Grow with Children
On 1 October 2026, FDA approved the Autus Size-Adjustable Valve, a surgically implanted pulmonary heart valve for pediatric patients with congenital pulmonary valve disease.
FDA describes it as the first heart valve designed to be expanded after implantation to accommodate a child’s growth.
It is also the first heart valve approved in the United States to use polymeric leaflets rather than animal-derived tissue.
The valve can initially be implanted at approximately 13 mm in diameter and subsequently expanded by balloon catheter up to 22 mm.
The PMA approval was supported by a clinical study involving 62 pediatric patients at 12 U.S. sites.
FDA said longer-term studies are continuing to further evaluate the device and the use of post-implantation valve expansion.
The Autus valve is also the first pediatric approval to emerge from FDA’s Total Product Life Cycle Advisory Program, or TAP.
The approval represents a first-of-its-kind device design for pediatric pulmonary valve replacement and a notable milestone for FDA’s TAP programme.
Read the dedicated insight: FDA Approves a Pediatric Heart Valve That Can Be Expanded as Children Grow
Source: FDA
Reference: FDA Approves First Heart Valve Designed to Grow with Children, FDA
FDA Publishes MDUFA V Independent Assessment
On 30 September 2026, FDA published an independent third-party assessment of programmes and commitments under the Medical Device User Fee Amendments of 2022, or MDUFA V.
The assessment was conducted by Booz Allen Hamilton.
It covers areas including premarket review efficiencies, the Q-Submission and Third Party Review programmes, Digital Health, Patient Science and Engagement, Real-World Evidence, international harmonisation and progress on Total Time to Decision.
The report concludes that, as of its publication date, FDA had met the relevant commitments for the programme areas included in the independent assessment.
It also notes that a number of commitments have future or recurring deadlines extending through the remainder of the MDUFA V period.
The assessment provides a consolidated status check on several device-review programmes and process commitments under the current MDUFA cycle.
Source: FDA
Reference: MDUFA V Independent Assessment — September 2026, FDA
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