The week of 14–20 September 2026 brought several relevant regulatory updates in the medical device and in vitro diagnostic (IVD) sectors.
This edition covers FDA’s decision to maintain 510(k) requirements for certain radiology computer-aided detection, diagnosis and triage software, draft guidance on electronic PMA submission templates, and a new ISO standard setting requirements for process development for sterile medical-device packaging.
The week also included an MHRA safety communication on wireless cardiotocography systems and an updated Health Canada compliance and enforcement policy covering health products, including medical devices.
In this issue
- FDA denies 510(k) exemption for radiology CAD and triage software
- FDA issues draft guidance on electronic submission template for PMAs
- MHRA highlights RF safety risks in wireless CTG monitoring systems
- ISO Publishes ISO 11607-3 on Requirements for Process Development for Forming, Sealing and Assembly of Sterile Medical-Device Packaging
- Health Canada updates compliance and enforcement policy for health products
FDA Denies 510(k) Exemption for Radiology CAD and Triage Software
On 17 September 2026, FDA published a final order denying a petition for partial exemption from 510(k) requirements for four categories of radiology computer-aided detection, diagnosis and triage software.
The petition covered radiological CADx software for lesions suspicious of cancer, medical image analyzers, radiological CADt software and combined computer-assisted detection and diagnosis software.
FDA had denied the petition on 1 April 2026 and has now formally set out its final determination.
The Agency concluded that the information presented did not demonstrate that premarket notification was unnecessary to provide reasonable assurance of safety and effectiveness.
As a result, these device categories remain subject to 510(k) premarket notification and FDA clearance before marketing.
The order confirms the continued role of premarket review for several software-based radiology device categories, including CAD and triage functions.
Source: FDA
Reference: Medical Devices; Exemption From Premarket Notification: Radiology Computer-Aided Detection and/or Diagnosis Devices and Computer-Aided Triage and Notification Devices, FDA
FDA Issues Draft Guidance on Electronic Submission Template for PMAs
On 17 September 2026, FDA issued draft guidance on the electronic submission template for Premarket Approval applications and certain PMA supplements submitted to CDRH and CBER.
The document remains Draft — Not for Implementation.
The draft covers Original PMAs, Panel-Track Supplements, 180-Day Supplements, Real Time Supplements and 30-Day Notices/135-Day Supplements.
It introduces the resources and structured content intended to support electronic preparation and submission of these applications.
When finalised, the guidance is intended to establish further electronic-format standards, an implementation timetable and criteria for waivers and exemptions.
Comments are requested by 17 November 2026.
The draft represents another step in FDA’s move towards structured electronic templates for medical-device premarket submissions.
Source: FDA / CDRH / CBER
Reference: Electronic Submission Template for Premarket Approval Applications, PMA, FDA
MHRA Highlights RF Safety Risks in Wireless CTG Monitoring Systems
On 17 September 2026, MHRA published Device Safety Information DSI/2026/012 following a review of wireless cardiotocography systems using radiofrequency telemetry channels.
The review identified signal crossover, erroneous CTG traces and signal dropouts as patient-safety risks associated with these systems.
MHRA notes that, in rare circumstances, signal crossover can result in the fetal heart rate from one CTG monitor being displayed on another monitor operating on the same RF channel.
Such events may result in misinterpretation of CTG traces and inappropriate clinical decisions.
The communication addresses wireless CTG systems as a device category rather than a single manufacturer or product.
The notice highlights a category-wide interoperability and signal-management risk in wireless fetal monitoring systems.
Source: MHRA
Reference: Radiofrequency Safety Considerations for Wireless Cardiotocography Monitoring Systems, DSI/2026/012, MHRA
ISO Publishes ISO 11607-3 on Requirements for Process Development for Forming, Sealing and Assembly of Sterile Medical-Device Packaging
ISO published ISO 11607-3:2026, a new first edition setting out requirements for process development for forming, sealing and assembly of packaging for terminally sterilised medical devices using heat-sealing technologies.
The standard applies to both preformed sterile barrier systems and sterile barrier systems.
It uses the sterile barrier system specification and risk-management principles to support development of the process specification.
The standard also addresses minimum heat-sealing equipment features relevant to subsequent validation, process control and monitoring.
ISO states that Part 3 is intended to be used before process validation.
ISO 11607-2 continues to provide the requirements for process specification and process validation.
The new standard expands the ISO 11607 framework with dedicated requirements for the process-development stage of heat-sealed sterile barrier packaging.
Source: ISO
Reference: ISO 11607-3:2026 — Packaging for terminally sterilized medical devices — Part 3: Requirements for process development for forming, sealing and assembly, ISO
Health Canada Updates Compliance and Enforcement Policy for Health Products
On 15 September 2026, Health Canada published an updated Compliance and Enforcement Policy for Health Products, POL-0001, replacing the previous version of the policy.
Medical devices are explicitly included within its scope.
The policy describes Health Canada’s national approach to compliance monitoring and enforcement under the Food and Drugs Act.
For medical devices and other regulated health products, its scope includes activities such as advertising, sale, manufacturing or fabrication, packaging and labelling, testing, importing, distribution, wholesaling and clinical trials.
The document also sets out a risk-based framework for selecting compliance and enforcement actions.
These actions can include inspections and monitoring, recalls, stop-sale actions, product seizure and actions relating to licences or authorisations.
The update provides the current framework used by Health Canada to describe its compliance and enforcement approach across health products, including medical devices.
Source: Health Canada
Reference: Compliance and Enforcement Policy for Health Products, POL-0001, Health Canada
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