This fortnight's edition spans a busy period for regulatory-affairs teams operating across the US, UK and global markets. The FDA has published a cluster of de novo classification orders effective early October, opening 510(k) pathways for several device types—and importantly exempting certain toxicology test systems from premarket notification altogether. In the UK, the government has thrown its full weight behind the NHS AI Commission's 44 recommendations, the MHRA's AI Airlock sandbox has entered a new phase, and fresh real-world evidence guidance has landed. Meanwhile, the CMS RAPID pathway debate continues to evolve on market access. Regulatory affairs leads should review the classification and exemption orders immediately to assess whether product lines are affected.
FDA Exempts Certain Class II Clinical Toxicology Test Systems from 510(k) — Effective Immediately
FDA · US
This final order removes premarket notification requirements for specified class II clinical toxicology test systems with immediate effect (6 October 2026). Manufacturers of in-scope devices can eliminate the time and cost of a 510(k) submission. Regulatory teams should audit their product portfolios against the exempted device codes now, and ensure quality-system and labelling obligations under special controls are still met—exemption from 510(k) does not mean exemption from other requirements.
Read the source →FDA Classifies STI Nucleic-Acid Home-Collection Test Systems as Class II (Special Controls)
FDA · US
Effective 9 October 2026, the FDA has established a de novo classification for systems detecting nucleic acid from non-viral STI microorganisms using home-collected specimens, placing them in class II under special controls. This creates a 510(k) predicate pathway for future entrants and sets the performance and labelling bar. IVD and diagnostics manufacturers developing home-use or direct-to-consumer STI tests must now design to these special controls to achieve clearance.
Read the source →FDA Classifies Infant OTC Pulse Rate & SpO₂ Monitor as Class II (Special Controls)
FDA · US
A new de novo order (effective 9 October 2026) opens an over-the-counter pathway for infant pulse oximeters under class II special controls. This is strategically significant for consumer and paediatric device makers: it defines the regulatory route, performance requirements and labelling obligations for a high-demand product category. Manufacturers already in development or holding a 510(k) pipeline should review the special controls for immediate impact on their technical files.
Read the source →FDA Classifies High-Throughput DNA Sequencing for Hereditary Cancer Predisposition as Class II
FDA · US
Effective 6 October 2026, this de novo order establishes class II status with special controls for high-throughput DNA sequencing systems used in hereditary cancer risk assessment. It creates a 510(k) predicate and defines the analytical and clinical validation requirements that future applicants must meet. Genomics and oncology diagnostics developers should map their existing technical documentation against the new special controls without delay.
Read the source →UK Government Backs All 44 NHS AI Commission Recommendations; MHRA AI Airlock Enters Next Phase
MHRA · UK
Ministers have accepted the full blueprint of the independent NHS Doctors-Led AI Commission, including a mandate for continuous, lifecycle-long oversight of AI-enabled medical devices. Simultaneously, the MHRA's AI Airlock regulatory sandbox—a collaborative, first-of-its-kind programme for AI Medical Devices—has opened its next phase. For manufacturers of AI/ML-driven devices targeting the UK market, this signals that post-market surveillance obligations will tighten considerably and that early engagement with the Airlock sandbox may provide a meaningful competitive and regulatory advantage.
Read the source →MHRA Publishes Real-World Evidence Knowledge Hub and Guidance for Medicines & Devices
MHRA · UK
The MHRA has consolidated its guidance, publications and resources on the use of real-world data (RWD) and real-world evidence (RWE) in UK regulatory decision-making for both medicines and medical devices. As post-market clinical follow-up (PMCF) requirements under UK MDR equivalents intensify, and as RWE becomes a more accepted input into benefit-risk assessments, regulatory affairs teams should review this hub to understand what evidence standards the MHRA expects and how RWE can be structured to support future submissions or label extensions.
Read the source →Nova Biomedical StatStrip Ketone Test Strips Recall: QC Failures and Supply Disruption (DSI/2026/013)
MHRA · UK
The MHRA has issued a device safety investigation notice following Nova Biomedical's recall of specified lots of StatStrip ketone test strips due to quality-control failures. Beyond the immediate patient-safety concern, this case is a timely reminder for IVD manufacturers of the supply-chain fragility risks embedded in lot-specific QC processes and the regulatory obligation to proactively notify competent authorities. Manufacturers of point-of-care test strips should review their lot-release procedures and FSCA escalation protocols.
Read the source →Medtech Lobby Pushes CMS to Broaden RAPID Pathway Device Eligibility
INDUSTRY · GLOBAL
AdvaMed has formally called on CMS to expand eligibility for the proposed RAPID (Rapid Access Pathway for Innovative Devices) coverage route to include more breakthrough devices—particularly diagnostics—and to mandate set timelines for national coverage determinations (NCDs). For small and mid-sized manufacturers seeking a faster route from FDA clearance to Medicare reimbursement, the scope of RAPID will be material to US commercial strategy. Regulatory and market-access teams should monitor the rulemaking response and prepare data packages that align with breakthrough device criteria.
Read the source →