This issue covers a busy fortnight dominated by a significant wave of FDA de novo classification orders spanning orthopaedics, neurology, IVDs, radiology AI and more — each establishing new Class II special-controls pathways that will shape 510(k) strategy for comparable devices. On the UK side, MHRA has refreshed its Innovation Accelerator and borderline-product guidance, offering practical routes for companies with novel or boundary-crossing products. We also flag the resolution of the Whoop warning letter as a useful case study in wellness-device compliance, and a ZOLL quality-system enforcement action as a timely reminder of FDA QMS scrutiny.
FDA Classifies Radiological ML-Based Quantitative Imaging Software with Predetermined Change Control Plan into Class II
FDA · US
This de novo order establishes a Class II special-controls framework specifically for AI/ML radiology software that includes a Predetermined Change Control Plan (PCCP). For software-as-a-medical-device (SaMD) developers, this creates a defined 510(k)-eligible predicate pathway — and signals FDA's expectation that future algorithm-change management should be built into submissions from the outset. Manufacturers developing radiology AI tools should review the special controls and PCCP requirements now to align their technical files and post-market processes accordingly.
Read the source →FDA Classifies SARS-CoV-2 Serology Test into Class II (Special Controls)
FDA · US
With COVID-19 EUAs being systematically revoked (three further authorisations — including BD Veritor and Roche Elecsys — were formally revoked this period), this classification order provides the long-term regulatory home for SARS-CoV-2 serology IVDs. Manufacturers still holding or planning commercial serology products must now plan for 510(k) clearance against the new special controls rather than relying on emergency-use pathways. This also has downstream implications for EU MDR and UKCA conformity assessments where US clearance is used as supporting evidence.
Read the source →FDA Classifies External Lower Extremity Nerve Stimulator for Restless Legs Syndrome into Class II
FDA · US
This order establishes a new Class II category for non-implantable peripheral nerve stimulators targeting RLS — a growing therapeutic area. The defined special controls create a viable 510(k) route for competitors and expand the neuromodulation predicate landscape. Companies developing wearable or external neurostimulation devices for chronic conditions should map their indications against this and other recent classification orders to assess predicate strategy.
Read the source →FDA Classifies Computerized Behavioral Therapy Device for Fibromyalgia into Class II
FDA · US
Digital therapeutics (DTx) developers take note: FDA has formally classified a software-based behavioural therapy device for fibromyalgia symptoms as Class II. This adds to the growing library of DTx predicates and clarifies the regulatory expectations — including special controls — for cognitive or behavioural software targeting chronic pain conditions. Relevant to manufacturers positioning products in the DTx space across the US market and seeking comparable frameworks under EU MDR Article 22 or UKCA.
Read the source →FDA Classifies Medial Knee Implanted Shock Absorber into Class II (Special Controls)
FDA · US
The classification of this implantable orthopaedic device into Class II — rather than the more burdensome Class III — is significant for the joint-preservation device sector. The established special controls will govern performance testing, biocompatibility, sterility and clinical data requirements for 510(k) submissions. Orthopaedic device manufacturers and their EU MDR/UKCA technical-file teams should review the special controls as a benchmark for equivalent conformity assessment evidence packages.
Read the source →MHRA Refreshes Borderline Products Guidance for Medical Devices
MHRA · UK
MHRA has updated its guidance on how it determines whether a borderline product falls within medical devices regulations under the UK framework. For companies with combination products, software, wellness devices or novel therapeutic modalities targeting the UK market, understanding MHRA's decision-making criteria is essential before committing to a regulatory pathway. This is particularly relevant post-Brexit where MHRA determinations diverge from EU MDR qualification opinions issued by competent authorities or the European Commission.
Read the source →MHRA Innovation Accelerator: Enhanced Access to Scientific and Regulatory Expertise
MHRA · UK
MHRA's Innovation Accelerator offers small and innovative device manufacturers direct access to MHRA scientific expertise and bespoke regulatory guidance — a resource that is disproportionately valuable for SMEs without large in-house regulatory affairs teams. The refreshed publication coincides with updated Innovation Office guidance and new case studies showing real-world navigation of MHRA processes. Regulatory leaders should evaluate whether their pipeline products qualify for accelerator support, particularly those involving novel technologies, software or combination approaches.
Read the source →FDA Closes Whoop Warning Letter After Blood Pressure Feature Changes — A Wellness-Device Compliance Case Study
INDUSTRY · GLOBAL
FDA's decision to close the warning letter against Whoop after the company modified its blood pressure insights feature illustrates the practical boundary between wellness claims and regulated medical device functionality. For manufacturers of consumer health wearables, fitness trackers or digital health apps, this case confirms that feature-level claim changes — without full device re-design — can satisfy FDA's requirements. Regulatory teams should use this as a reference point when reviewing labelling, marketing claims and intended-use statements for products near the wellness/medical device boundary, including under MHRA's updated borderline guidance.
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