SVP Global Regulatory and Quality
The AMDM IVD Focus Fall Meeting brought together regulators, industry leaders, and diagnostic professionals for two days of focused discussion and actionable insight. The meeting focused on the current and emerging regulatory landscape for in vitro diagnostics (IVDs), providing clarity on implementation priorities, policy shifts, and the operational realities of compliance in 2026 and beyond.
U.S. Regulation and Policy Landscape
Sessions on U.S. regulatory developments opened with reflections on the federal government shutdown and its operational effects on FDA activities. While essential health and safety functions and reviews supported by existing user-fee funds continue, many new submissions and policy initiatives remain paused until appropriations resume.
A discussion of the Loper Bright legal decision highlighted how the rescinded LDT Rule and evolving interpretations of agency authority will continue to influence FDA’s approach to laboratory-developed tests (LDTs). While FDA’s direct authority over LDTs has been clarified, the Agency may still exert oversight through several indirect pathways — including regulation of collection devices, research-use-only (RUO) products, and requirements tied to companion diagnostics during the associated drug and biologic approvals.
Beyond LDTs, speakers highlighted FDA’s expanding oversight of emerging technologies such as software-based diagnostics and wellness devices. The discussion noted the Agency’s growing attention to wellness wearables — low-risk products that promote healthy lifestyles — and the FDA’s position on software functions that may qualify for general wellness exemptions or fall under stated enforcement discretion.
Across several sessions, a consistent message emerged: even under enforcement discretion, manufacturers are expected to maintain robust design control, validation, and quality management systems.
2025 Legislative Priorities
Meeting discussions highlighted several legislative initiatives likely to shape the next phase of diagnostic policy:
- Protecting Access to Medicare Act (PAMA) reform, aimed at establishing a sustainable reimbursement framework for diagnostic innovation, and the Reforming and Enhancing Sustainable Updates to Laboratory Testing Services (RESULTS) Act. The latter is a proposed bill to reform Medicare’s lab test payment system, address flaws in the current data collection method, and prevent major payment cuts that could threaten patient access to testing.
- The Patients Deserve Price Tags Act, a proposed bill that aims to increase transparency in healthcare costs.
- The Ensuring Patient Access to Critical Breakthrough Products Act, proposed legislation that would create a four-year, automatic temporary Medicare coverage period for FDA-designated breakthrough devices, requiring CMS to make a permanent determination within that time. In contrast, TCET (Transitional Coverage for Emerging Technologies) is an administrative pathway created by CMS, which is more restrictive, limits devices to five per year, requires a separate application, and doesn’t guarantee coverage. Of note, in September 2025, the Ways and Means Committee passed an amended version of the Ensuring Patient Access to Critical Breakthrough Products Act that excludes in vitro diagnostics from scop.
- The Medicare Multi-Cancer Early Detection Screening Coverage Act – proposed legislation to create a pathway for Medicare to cover multi-cancer early detection (MCED) blood tests after they are approved by the FDA and determined to have clinical benefit.
Together, these priorities aim to balance innovation, patient access, and predictable oversight.
Implementing FDA’s Quality Management System Regulation (QMSR)
Although ISO 13485:2016 and the current CGMP requirements for devices in 21 CFR Part 820 are substantially similar, the FDA’s forthcoming Quality Management System Regulation (QMSR), effective February 2, 2026, incorporates ISO 13485:2016 by reference while maintaining key FDA-specific provisions.
Manufacturers already compliant with ISO 13485 should note that several FDA-specific definitions and expectations remain. Beyond the ISO clauses, the QMSR preserves historical Part 820 provisions related to:
- Risk management
- Control of records (including claims, labeling, and packaging)
- Electronic records and signatures compliance
Device manufacturers may need targeted process updates and internal training to ensure full alignment before February 2026.
Global Regulatory Perspectives: IVDR and Health Canada
Transition to the EU In Vitro Diagnostic Regulation (IVDR) remains a critical focus area.
- Class D devices are already transitioned under the IVDR.
- Manufacturers of Class C legacy IVDs must lodge applications to a notified body for conformity assessment by May 26, 2026, and by May 26, 2027 for Class B and A (sterile) devices that were self-declared under the IVDD.
While notified body capacity has improved, review timelines remain long — often 13 to 18 months for combined QMS and product certificates.
Common issues identified during Notified Body reviews include product misclassification, inconsistent intended purpose statements, missing documents required by Annex II/III, and clinical evidence that does not meet IVDR expectations.
Health Canada updates to the Medical Device Regulations (SOR/98-282) focused on recall definitions, reporting and record-keeping, and modernization of MDEL application requirements—changes that took effect December 14, 2024.
Companion Diagnostics (CDx): Coordination and Collaboration
The evolution of companion diagnostics (CDx) continues to highlight the increasing interdependence between drug and diagnostic development.
Conducting early-phase clinical investigations with non-CE-marked products, especially when a CDx may be in scope, remains challenging despite additional MDCG guidance. Key pain points include the adequacy of analytical performance data, clarity on roles and responsibilities (e.g., study sponsorship), and interpretation of clinical evidence when different assays are used within a study or alongside the investigational medicinal product.
EMA consultation timelines and notified body reviews remain gating factors for drug/CDx contemporaneous approval, often driving the need for parallel data strategies across jurisdictions. Successful CDx programs emphasize cross-functional collaboration—linking regulatory, clinical, and analytical teams from concept through commercialization to ensure synchronized regulatory outcomes.
Design and Delivery: Cybersecurity, Self-Collection Devices, and Human Factors Usability Studies
Cybersecurity
Cybersecurity expectations are now embedded across the device lifecycle. FDA’s approach — consistent with NIST SP 800-218 — treats cybersecurity as part of quality system management, encompassing secure design, verification and validation, postmarket monitoring, and coordinated vulnerability disclosure.
Manufacturers were encouraged to document threat modeling, maintain vulnerability management programs, and ensure supplier controls and software updates are traceable to cybersecurity risk mitigations. Documentation should link cybersecurity risk management directly to design controls and product safety — reinforcing that security is intrinsic to device effectiveness, not an afterthought.
Human Factors Usability Studies: Self-Collection and Over-the-Counter (OTC) Devices
Devices intended for use outside professional settings — whether self-collection kits or over-the-counter (OTC) diagnostics — must integrate risk management with user interface design to ensure safety, accuracy, and ease of use.
For self-collection devices, the user interface must be intuitive, logical, and easy to navigate to minimize handling errors and ensure adequate specimen quality. Early formative studies, conducted during development, help refine interface elements and identify use-related risks. Design simplification that prioritizes comfort, clarity, and intuitive interaction improves both sample adequacy and user confidence.
For OTC diagnostics, FDA requires human factors usability studies to demonstrate that untrained users can safely and effectively perform the test and interpret results. Simplified workflows, clear visual cues, and intuitive interfaces improve accuracy and reduce invalid outcomes. Success depends on conducting formative studies early and iteratively, as design changes can introduce new usability issues.
Summative usability studies, performed by intended users in the intended environment and incorporating the complete testing workflow, should confirm that the user interface is free from unacceptable risk.
The key takeaway: whether for self-collection or OTC IVDs, human factors usability studies are integral to safe and effective product performance. Iteration, simplicity, and communication are essential to delivering reliable results and satisfying FDA’s expectations for the growing arena of lay-user diagnostics.
How Beaufort Can Help
As global diagnostic regulation continues to advance, success depends on transforming regulatory complexity into clear, executable strategy. At Beaufort, we help diagnostic and device manufacturers stay ahead of evolving requirements — aligning design, quality, and compliance from the earliest stages of development through market readiness.
Our multidisciplinary team translates policy into practice, guiding manufacturers through FDA and global frameworks with precision and foresight. By integrating regulatory intelligence with operational execution, we enable clients to anticipate change, strengthen quality systems, and accelerate access to innovative diagnostic technologies.
Beaufort helps innovators turn regulatory shifts into market momentum — empowering our clients to advance diagnostic technologies that can make a measurable difference.