Overview
June 2026 has been an important month for medical device regulatory teams in the United States and Canada.
Several updates affect active submissions, upcoming FDA filings, Human Factors documentation, digital health strategy, and Canadian medical device establishment licensing. For manufacturers preparing 510(k), De Novo, PMA, IVD, digital health, software, or Canadian import and distribution activities, these changes should not be treated as background regulatory news. They may directly affect submission planning, documentation readiness, and compliance procedures.
Below are four key updates medical device companies should review.
1. FDA updated eSTAR on June 1, 2026
FDA updated the eSTAR Program page on June 1, 2026. The non-In Vitro Diagnostic (nIVD) and In Vitro Diagnostic (IVD) eSTAR templates now include content from FDA’s new Human Factors Content Guidance, which was published on May 29, 2026 and becomes effective on August 1, 2026.
FDA also lists the updated nIVD and IVD eSTAR templates as Version 7.0. The previous Version 6.2 templates are scheduled to retire on August 3, 2026.
This is important for teams currently preparing FDA submissions. If a 510(k), De Novo, PMA, or IVD submission is in progress, the submission team should confirm which eSTAR version is being used and whether the Human Factors content expectations are properly addressed.
FDA indicates that older eSTAR versions may still be submitted until the retirement date, but submissions prepared using older versions may receive additional information requests if there are differences between the submitted version and the updated version.
Practical takeaway
Manufacturers should review active eSTAR files now, especially for submissions expected to be filed close to or after August 2026.
At minimum, teams should confirm:
- The current eSTAR version being used
- Whether the device has user interface related risks
- Whether a Human Factors submission category has been determined
- Whether Human Factors documentation is aligned with FDA’s current expectations
- Whether any planned submission date falls after the Version 6.2 retirement date
Teams preparing FDA submissions may benefit from a structured readiness review before filing. See the FDA Mock Deficiency Review and broader Regulatory Readiness Stress Tests service line.
2. FDA Human Factors expectations are becoming more embedded in submissions
FDA’s final guidance, Content of Human Factors Information in Medical Device Marketing Submissions, introduces a risk-based framework for determining what Human Factors information should be included in marketing submissions.
The guidance applies to premarket notifications, De Novo requests, premarket approval applications, and humanitarian device exemption applications. It is intended to promote consistency and improve the efficiency of FDA review.
This is especially important for devices where safe and effective use depends on the user interface, instructions for use, software workflows, alarms, displays, accessories, home-use conditions, lay users, or critical tasks.
The significance of this update is not only the guidance itself. FDA has now integrated Human Factors content into the eSTAR structure. That means Human Factors is no longer something that can be addressed informally or added late in the submission process. It is becoming more directly embedded into the submission pathway.
Practical takeaway
Manufacturers should not wait until the end of development to decide how to address Human Factors.
Teams should review whether they have:
- Defined intended users, use environments, and use scenarios
- Identified critical tasks
- Evaluated use-related hazards and harms
- Linked Human Factors considerations to risk management
- Documented formative evaluations, if applicable
- Justified whether validation testing is required
- Ensured IFU, labeling, training, and user interface materials are aligned
For many devices, especially software-enabled, home-use, connected, or lay-user devices, Human Factors can become a major review issue if it is not planned early. Panabistics offers a focused Human Factors & Usability Review and related Human Factors training programs.
3. CDRH June updates continue to highlight digital health, AI, AR/VR, sensor-based technologies, recalls, and classifications
FDA’s CDRH news and updates page continues to show significant activity around emerging technologies and post-market safety topics.
June 2026 updates include activity related to:
- Artificial Intelligence-enabled medical devices
- Augmented Reality and Virtual Reality medical devices
- Sensor-based digital health technologies
- Medical device shortages
- Early alerts
- Recalls and corrections
- Federal Register classification notices
This reflects a broader trend. FDA continues to build out its public resources and regulatory approach for digital health, software, AI-enabled devices, sensor-based technologies, and emerging device platforms.
For manufacturers developing digital health products, these updates should be reviewed as part of regulatory strategy, not just marketing intelligence. Public FDA resources can provide insight into how the Agency is thinking about transparency, device authorization, safety and effectiveness, real-world performance, and patient-facing technologies.
Practical takeaway
Digital health and software-driven device companies should review whether their regulatory files are keeping pace with FDA expectations.
This includes:
- Software documentation
- Cybersecurity documentation
- AI/ML lifecycle documentation, if applicable
- Predetermined Change Control Plan considerations, if applicable
- Human Factors documentation
- Clinical performance strategy
- Real-world performance monitoring
- Post-market surveillance and complaint handling procedures
- Labeling, transparency, and user communication
Digital health products are moving quickly, but regulatory expectations are also becoming more structured. Relevant Panabistics reviews include Software Documentation Review, Cybersecurity Review, and the full FDA Mock Deficiency Review.
4. Health Canada announced Phase 2 of MDEL modernization
On June 17, 2026, Health Canada announced Phase 2 of its work to modernize medical device establishment licensing. See the Phase 2 MDEL modernization bulletin.
The amended regulations are scheduled to come into force on December 14, 2026, 180 days after publication in Canada Gazette, Part II. Health Canada also issued an updated version of the Guidance on medical device establishment licensing (GUI-0016), which is for reference now and becomes effective on December 14, 2026.
The key amendments include:
- Removing the requirement for certain foreign distributors to hold an MDEL when they sell medical devices through Canadian importers that already hold an MDEL
- Clarifying the requirement for MDEL holders to establish, implement, and maintain documented procedures
- Requiring MDEL applicants and holders to provide a list of suppliers for medical devices they import or distribute in Canada
Health Canada stated that the amendments are intended to reduce burden for industry, clarify regulatory requirements, improve transparency around devices imported into Canada, and better align with international regulations.
Practical takeaway
Companies involved in importing or distributing medical devices in Canada should review their MDEL status and procedures before December 14, 2026.
This is particularly important for:
- Canadian importers
- Canadian distributors
- Foreign distributors selling into Canada
- Class I manufacturers
- Private label and OEM distribution models
- Companies relying on third-party importers or distributors
Organizations should also review supplier lists, documented procedures, annual licence review practices, and role definitions between manufacturer, importer, distributor, retailer, and ultimate consumer. Learn more about Panabistics MDEL services.
Why these updates matter
The common theme across these updates is that regulatory expectations are becoming more operational and more structured.
FDA is embedding Human Factors expectations directly into eSTAR. CDRH continues to focus on digital health, AI, AR/VR, sensor-based technologies, recalls, and classifications. Health Canada is modernizing MDEL requirements and clarifying establishment licensing responsibilities.
For medical device companies, this means regulatory readiness should not be limited to checking whether a submission template is complete. Teams need to ensure that the underlying technical documentation, risk management file, usability engineering file, software documentation, cybersecurity file, labeling, supplier controls, and post-market procedures can support the regulatory position being taken.
Recommended actions for manufacturers
Medical device manufacturers should consider taking the following actions:
- Review active FDA submissions and confirm whether the correct eSTAR version is being used.
- Review Human Factors documentation against FDA’s new risk-based submission framework.
- Confirm that user interface risks, critical tasks, IFU, labeling, and risk controls are aligned.
- For software, AI, sensor-based, or connected devices, review digital health documentation, cybersecurity, and post-market monitoring expectations.
- For Canadian activities, review MDEL applicability, supplier lists, documented procedures, and importer/distributor roles before the December 14, 2026 effective date.
- Update internal regulatory trackers, QMS procedures, and submission planning templates to reflect the June 2026 updates.
How Panabistics can help
Panabistics supports medical device companies with FDA submissions, eSTAR readiness, Human Factors and usability engineering documentation, software and SaMD regulatory strategy, cybersecurity documentation, Health Canada licensing, MDEL compliance, and QMS readiness.
If your team is preparing a 510(k), De Novo, PMA, IVD submission, digital health submission, or Canadian market entry strategy, now is the right time to confirm that your documentation is aligned with current regulatory expectations.
Panabistics helps manufacturers identify gaps before regulators do. Explore our Regulatory Readiness Stress Tests, FDA Mock Deficiency Review, focused module reviews, and contact us to discuss scope.
Panabistics Corp.
Navigating the Future of MedTech Compliance