On the Reg is a new initiative to spotlight strategy, opinion, and insights from the neurotech field’s evolving regulatory landscape. It’s written for and by commercial leaders and experts from our audience of engaged readers.
Last month we called for a 50 day/50 year lens on regulatory reforms, and shared FDA news with experts views on timelines, home-based innovation, mental health, and other topics.
This month, our roundup highlights federal program guidance, state level regulation, and coverage of recent decisions, leadership shuffles, and more. While devices remain a seeming afterthought in much of the drug regulation discussion today, numerous opportunities to advance new devices through the FDA are also evolving positively.
Neurovalens De Novo Clearances Demonstrate FDA’s Assessment Flexibility
New Vermont Law Puts Neurotech on Notice
FDA Guidance on Adjunctive Pain Measurement Devices for Anesthesiology
Do FDA’s New Leaders Know About Devices and Does It Matter?
Examples of CDRH Decisions Made with Real-World Evidence
Finalized Human Factors guidance for upcoming device submissions
FDA’s new “reciprocal staff-sharing initiative with the UK
Reading Riders: Clinical Trial Reforms on the Horizon?
Thanks to Mittal Consulting, The Silverman Group, Cooley LP, and the FDA Law Blog for the coverage informing this issue. Scroll to the bottom & Hit Reply if you want to contribute to next month’s issue!
By: Susan Lubejko PhD and Abigail Copeland PhD, Regulatory Affairs Specialists at Mittal Consulting
While it may seem surprising, medical devices with the same technological characteristics but different clinical applications sometimes receive different classification from FDA. It all comes back to a device’s benefit-risk framework. The phrase “benefit-risk framework” is often used in medical device regulation as the mechanism that FDA uses for device classification. Considering the benefit-risk of a medical device to determine its classification may seem straightforward in terms of technological characteristics, but the context of its intended use is also key to consider as there may be substantial differences in regulatory and evidentiary requirements.
An interesting case study illustrating this arises with recent De Novo authorizations from Neurovalens. Last month, Neurovalens’ De Novo clearance for Class II Modius Spero (DEN250013) expanded its non-invasive vestibular nerve stimulation (VeNS) device platform into the treatment of post-traumatic stress disorder (PTSD). This expansion builds upon a previous De Novo authorization of Neurovalens’ Class I Modius Lean (DEN240076), which utilizes the same technology for weight management. These authorizations provide a clear example of how a single device technology can fall into different risk-based device classifications depending on intended use, thus impacting regulatory, evidentiary, and commercialization requirements.
As noted, Modius Lean and Modius Spero use the same VeNS technology, suggesting that the devices present the same direct risk of physical harm to patients. However, FDA has classified Modius Lean as a Class I medical device (despite using longer durations of electrical stimulation) and Modius Spero as a Class II device, insinuating that FDA’s consideration of the direct physical risk associated with VeNS is minor, and that the differentiation likely comes from the relative amount of risk contributed by the indications. In PTSD, ineffective treatment may lead to worsening of anxiety or PTSD symptoms, while with a weight loss indication the risk of an ineffective therapy is considered to be lower. By directly comparing the two authorizations of the same technology from the same Sponsor, it is easy to see how the risk level of a device, even when the technology has been previously cleared, is highly influenced by the indication.
Further, from a testing analysis perspective, the clearance for Modius Lean demonstrates the relatively lower validation bar and threshold for potential benefit for medical devices that can successfully argue a low-risk designation. While it is uncommon for a Class I De Novo device to require clinical data, certain neurological devices do require use on humans to demonstrate their effect that can’t be captured in bench or animal testing. Interestingly, Neurovalens conducted a pivotal clinical study for Modius Lean which failed to meet its predefined primary endpoint of weight loss, while meeting secondary endpoints related to decreased visceral fat (Viirre et al. 2025). For Class II and III device sponsors, this result would be unacceptable to support a premarket submission; however, in the case of a Class I medical device like Modius Lean, FDA interprets this differently. During pre-market review, FDA considers the extent of the probable benefits of the intended use the of the device in relation to the probable risks. Neurovalens likely argued successfully that relatively lower benefit for weight loss was acceptable due to the low risk related to the technology itself, the weight loss indication, and the resulting Class I designation.
These case studies illustrate that thoroughly considering risk, both from a technological and intended use perspective, is key in determining device classification and thus regulatory and evidentiary requirements for successful market entry. To best communicate with FDA review teams on their premarket submissions, Sponsors should frame their justifications for device classification and testing using a holistic assessment of the relative benefits and risks of their devices.
Excerpted from the original article published by Cooley June 23, 2026
Vermont, a state famous for tapping maple trees, is now tapping into something far more complex: the human brain. With the enactment of S.71, the Vermont Data Privacy and Online Surveillance Act, the Green Mountain State has become the fifth state in the nation (after California, Colorado, Connecticut and Montana) to classify “neural data” as “sensitive data” subject to the most stringent privacy protections under state law.
For the rapidly expanding consumer neurotech industry – from EEG-enabled meditation headbands and neurofeedback wearables to emerging brain-computer interfaces – the law imposes consent requirements, purpose limitations and assessment obligations that impact how companies collect, use and monetize the data generated by measuring the activity of the human brain.
Crucially, the law contains no revenue threshold, meaning even early-stage startups processing neural data from as few as 3,000 consumers will find themselves subject to its full reach. However, the law contains exceptions for HIPAA protected health information, healthcare components of HIPAA covered entities and HIPAA business associates. Neurotech companies who make their products available to patients through the healthcare system might enjoy one of these exceptions.
Read on for an overview of defining neural data, defining who’s impacted, understanding consent, data sale, protection, enforcement timelines, and more.
Zooming out: Does anybody actually want more one-off neural data legislation? Hit Reply if you have strong perspective about this.
By Naveen Rao
On June 1, 2026, FDA published its final order establishing the Adjunctive Pain Measurement Device for Anesthesiology as a permanent device classification under 21 CFR §868.2200 (product code QVE), Class II, subject to special controls.
Say what? They are making it easier for “Adjunctive Pain Measurement Devices” to get regulatory clearances as class II, rather than III. “An adjunctive pain measurement device for anesthesiology is a prescription device that includes software algorithms to analyze physiological sensor data and measure response to painful stimuli in patients under general anesthesia. The device may be software-only or it may include hardware such as physiological sensors. This device type is intended for adjunctive use to tailor analgesic administration to a patient’s actual response to painful stimuli and is not intended to independently direct decision-making.”
So what? This is an attempt to catalyze innovations around opioid reduction through regulatory downsizing. It stemmed from a De Novo request submitted by Medasense Biometrics Ltd. for its PMD-200 nociception monitoring system, granted in February 2023. This new rule converts that one-time authorization into a standing regulatory category open to all market participants who want to work on the AI layer to decoding pain biomarkers with in-market devices.
Because this originates from a De Novo, any manufacturer with a substantially equivalent product may now pursue 510(k) clearance rather than a new De Novo or PMA. All future 510(k) applicants must demonstrate substantial equivalence to the PMD-200’s performance profile, including nociception subtype handling (somatic, visceral, neuropathic). Dig in here.
The special controls describe a heavy lift for any submission package: clinical validation against a reference nociceptive measure, segregated ML training and validation datasets, demographic performance breakdowns by age, sex, and race/ethnicity in labeling, usability engineering documentation, and explicit disclosure of opioid agent and dosing used in validation studies.
Companies that have not yet built this clinical validation infrastructure will face meaningful time and cost before submission. But the ‘software only’ device description and the opioid minimization motivation behind this reg, suggest (at least to me) that this could be a real opportunity for a lean startup/well-resourced team focused on advancing a pain biomarker discovery platform in a validated clinical market.
Hit Reply: Do you want to summarize and “translate” a recent Federal Register for business readers? Here are a few recent ones.
By: Steve Silverman, President of The Silverman Group and Editor at What the FDA, where the full version of this article originally appeared.
Views on Kyle Diamantas’s appointment as FDA’s acting Commissioner focus heavily on drugs and biologics and less on medical devices. That’s understandable given the dramatic circumstances of his appointment. But device questions remain: does Diamantas have the experience and expertise to supervise device regulation? Do other FDA leaders have enough device knowledge to support him? And given CDRH’s stable and capable leaders, how much commissioner-level oversight is needed?
What Should Device Firms Do?
Watchful waiting is a legitimate strategy. This FDA leadership environment rewards restraint. Diamantas hasn’t revealed a device-specific agenda, and the administration’s policy bandwidth is consumed by battles over abortion drugs and MAHA priorities. Device firms that keep low profiles steer clear of the crossfire. That means tracking matters relevant to the device sector – like MDUFA VI, CDRH staffing, and AI policy – and engaging when not acting would produce worse results.
Build the education brief. A commissioner who lacks deep device expertise isn’t an adversary; he’s a blank slate. Device firms and their trade associations should develop concise, credible materials explaining the stakes of key device policy issues.
Watch the commissioner’s calendar. Diamantas will eventually take meetings with device-sector stakeholders. Getting on his calendar early – before positions harden and before other regulated industries crowd it out – is crucial. Firms with a strong Washington presence will outperform those relying on less experienced, dispersed resources.
Read the whole piece for more context on Deimantas and other leadership.
By: Susan Lubejko PhD and Abigail Copeland PhD, Regulatory Affairs Specialists at Mittal Consulting
On May 29, 2026, FDA published its final guidance on Content of Human Factors Information in Medical Device Marketing Submissions. Sponsors should take note, as there are subtle changes in FDA requirements between the 2022 Draft of this document and this year’s final revision. This final version provides much more clarity on Human Factors requirements as well as implies a potentially lower burden for usability information for certain simple and widely used devices in premarket submissions starting on August 3rd.
Human factors (HF) validation, often called “usability”, evaluates how intended users interact with medical device interfaces in their use environment, ensuring that devices can be used safely and correctly. This guidance document provides a risk-based framework for Sponsors to determine HF content that should be included with their marketing submissions. FDA defines three HF Submission Categories with increasing documentation and validation needed for increasing use-related risk. To determine their HF Submission Category, Sponsors are directed to a flow chart that probes whether the device is an update to an existing device, whether the device has “critical tasks” (steps in the use workflow that could cause harm if done incorrectly), and whether there is a history of use with similar devices and interfaces. Category 1 and 2 devices need only high-level summaries of existing HF efforts and descriptions of users, environments and interfaces, whereas Category 3 devices require full risk analysis and usability testing information.
The most notable change between the 2022 draft guidance and this finalized one is a new node that has been added to the decision flowchart. Previously, all devices with identified critical tasks would be automatically assigned to HF Category 3 and required to produce testing documentation. The new decision point asks Sponsors to consider the question: “Should HF validation test data be submitted for my device?”. If a device has good justification that it is simple, risk control measures are adequate, and the interface has a robust use history with same the intended users, it can now fall into HF Category 2. If not, the device falls into HF Category 3. This change loosens HF documentation requirements for simple devices with documented use history, even if they have critical tasks. This potentially signals a new FDA posture on usability, after a period where full validation testing appeared to be required for most devices and testing specifics could only be discerned by direct discussions with FDA.
Changes to eSTAR templates for 510(k) and De Novo submissions also accompanied this final guidance. Previously, there was not a dedicated section in eSTAR for usability information, and its inclusion (or not) was relatively hidden. Now, on eSTAR 7.0 which takes effect on August 3rd, HF is a prominent section with specific required material based on the selected category. Although not required until August, Sponsors currently working on a submission that could extend into the fall should consider consulting the new guidance to ascertain their HF documentation burden. For some Sponsors, the documentation burden may actually be lower than expected – and for all Sponsors, FDA’s HF expectations have been made clearer.
“CDRH conducted an additional review of public-facing decision summaries for devices authorized between FY 2020-2025. CDRH identified 73 additional premarket Examples of Real-World Evidence Used in Medical Device Regulatory Decisions (Fiscal Years 2020–2025) that highlight the continued evolution and increasing sophistication of RWE applications.
Neurotech examples from this new report include PMAs for indication expansion based on registry data, Inspire’s OSA implant, and in MED-EL Corp’s cochlear implant, as well as PMAs for Phagenesis’s electronic stimulation system and Medtronic’s spinal cord stimulator’s expansion into diabetic peripheral neuropathy.
There are many more. Patient registries are about much more than building ‘top of funnel’ for a clinical study!
As per the FDA -
“Under the initiative, an FDA representative will be embedded at the MHRA headquarters in London while an MHRA representative will be embedded at the FDA’s headquarters in White Oak, Maryland. The initiative was announced by Grace Graham, FDA Deputy Commissioner for Policy, Legislation and International Affairs, and Lawrence Tallon, MHRA CEO, during a session at DIA Global in Philadelphia. Historically, the FDA has enjoyed a close working relationship with the MHRA, helped by the U.K.’s advanced health data infrastructure and robust academic and tech sectors, which have yielded many opportunities for collaboration and scientific exchange. The FDA job announcement can be found here.”
What does this mean? What is it for? Why is it happening? What do you think?
Summarized from the FDA Law Blog series, by Jennifer D. Newberger & Sara W. Koblitz & Deborah L. Livornese & Dara Katcher Levy & Mark A. Tobolowsky & Kalie E. Richardson & Riëtte van Laack & Mary Bass.
The FDA Law Blog just published a three-part series exploring the 143 FDA-related riders passed with the recent appropriations report, along with what that means and why it’s important.
What is a Rider? “In legislative procedure, a rider is an additional provision added to a bill or other measure under consideration by a legislature, which may or may not have much, if any, connection with the subject matter of the bill.”
Part One covers replacing Animal Testing (including organ on chip), drug inspections for overseas operations, a clampdown on Chinese clinical research (for drug submissions), Alzheimer’s Clinical Trials (including better diagnostics), Real-World Data and Evidence, and Women’s Health.
The most interesting to me was a rider that “directs FDA to revise its IND processes and data requirements for initial human trials to streamline administrative requirements, reduce filing burdens, and make them phase- and risk-appropriate and to consider developing a pilot program for lower-risk INDs more akin to Australia’s notification system.”
Adam Caplan of Jumpspace Ventures spoke about this on my NYBCI25 panel last year: “In Australia, you see a lot of companies going for First in Human (FIH) trials. It’s about a third of time to get through TGA compared to FDA, plus a 44% R&D tax credit. So not only do you pay the people a lot less, you get one in every two dollars back on what you spend, and you get through in a third of the time.”
Part Two groups major drug development topics, from gene and cell therapies, biosimilars, rare disease as well as prescribing, imports, accelerated approval, priority vouchers, and more. Part Three covers additional device updates, GLP-1s, compounding pharmacies, and other topics.
That’s a wrap! What regulatory headlines or headwinds should we cover next month? Hit Reply on any of the following:
Tell me about specific company approvals or clearances, or related trends analysis of markets, modalities, sectors.
Ditto for program level analysis and interpretation across FDA, CMS, other agencies.
Any global market developments or other topics.
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