Over the past few decades, the field of neurological devices has seen disruptive innovation, fueled by advances across the broader medical device industry. In response, FDA has continually adapted its review processes – both in practice and organizational structure – to keep pace with this evolution. The goal remains consistent: to ensure the safety, effectiveness, and clinical benefit of devices designed for neurological care. From traditional implants to cutting-edge, software-driven platforms, what does the neurological device landscape look like today – and how has the regulation of these devices evolved?
The Modern Neurological Device Landscape
Neurological devices encompass a wide range of technologies intended to detect, diagnose, treat, or support disorders of the central and peripheral nervous systems. These conditions span categories such as neurodegenerative diseases, neuromuscular disorders, and conditions affecting the brain, spine, and peripheral nerves – often in conjunction with other physiological systems.
Examples of neurological devices include neurostimulation systems, neuroimaging tools, neurosurgical and neurointerventional technologies, and diagnostic platforms. Over time, there has been a notable shift from traditional, hardware-based implants to hybrid devices that integrate complex software components. Innovations in artificial intelligence and machine learning are now frequently embedded in device design, bringing new challenges and opportunities in areas such as cybersecurity, human factors, and real-time performance monitoring.
How FDA Has Adapted
In the early days of neurological device reviews, FDA regulatory oversight fell under divisions that were not solely specialized in neurology. Historically, these devices were reviewed within the Division of General Restorative Devices – primarily aligned with orthopedic technologies. While sufficient at the time, this structure limited the FDA’s ability to address the unique risks and complexities of neurological technologies, particularly as they became more software-driven and connected.
Recognizing these limitations, the FDA gradually restructured its oversight. Here’s a quick look at how regulatory oversight for neurological devices at the FDA has shifted over time – note that these dates are based on information found in FDA’s publicly available clearance & approval databases, and therefore they are approximate:
- Pre-2008: Division of General Restorative Devices
- 2008–2010: Division of General, Restorative and Neurological Devices
- 2010–2014: Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices
- 2014–2019: Division of Neurological and Physical Medicine Devices
- 2019–Present: Office of Neurological and Physical Medicine Devices (OHT 5), under the Office of Product Evaluation and Quality (OPEQ)
A major turning point came in 2014, when neurological devices gained their own dedicated review division, allowing for more focused, consistent, and clinically informed evaluations of device safety and effectiveness. That structure was solidified in 2019 with FDA’s Total Product Life Cycle (TPLC) reorganization, resulting in today’s Office of Health Technology 5 (OHT 5): Office of Neurological and Physical Medicine Devices.
OHT 5 is organized into two Divisions of Health Technology (DHTs): DHT 5A (Neurosurgical, Neurointerventional and Neurodiagnostic) and DHT 5B (Neuromodulation and Rehabilitation Devices). Each of these DHTs is further divided into specialized sub-teams, each overseen by an Assistant Director. Like other OHTs, OHT 5 integrates both pre-market and post-market review, to ensure continuity and informed oversight across the product lifecycle.
As neurological devices have grown more advanced with features like AI, machine learning, digital health tools, wearables, and nanotechnology, OHT 5 has had to stay ahead. Reviewers now work closely with the FDA’s Digital Health Center of Excellence and engage manufacturers early through Q-submissions and interactive reviews. OHT 5 has also taken a leading role in assessing emerging technologies such as brain-computer interfaces (BCIs), adaptive neurostimulation, and other therapies that blend hardware, software, and real-time data.
FDA Pathways for Neurological Devices
Neurological devices span a wide spectrum of FDA classifications (Class I through III) with most currently regulated under 21 CFR Part 882. However, due to the complexity of these technologies, some devices also fall under other FDA review panels such as orthopedics, ENT, or ophthalmology, and may be regulated under other sections of 21 CFR. Depending on the device’s risk profile and novelty, regulatory submissions may follow the 510(k), De Novo, or Premarket Approval (PMA) pathways.
A rapidly growing area of interest is BCI systems. While no complete BCI system has yet received full FDA approval, several are in clinical trials or taking a stepwise regulatory approach – seeking clearance for individual components (e.g., brain mapping tools) while continuing broader system development. FDA’s 2021 guidance, Implanted Brain-Computer Interface (BCI) Devices for Patients with Paralysis or Amputation – Non-Clinical Testing and Clinical Considerations, outlines key considerations for design, risk management, and both non-clinical and clinical studies.
To further support progress in this space, FDA joined a collaborative community launched by Mass General Brigham in 2024, focused on advancing the safety, effectiveness, and accessibility of BCI technologies. Participating organizations include Synchron, Precision Neuroscience, Blackrock Neurotech, Neuralink, and the BCI Society. This cross-sector effort reflects the growing importance of public-private collaboration in addressing the unique regulatory and technical challenges of next-generation neurotechnology.
Neuroscience, Blackrock Neurotech, Neuralink, and the BCI Society. This cross-sector effort reflects the growing importance of public-private collaboration in addressing the unique regulatory and technical challenges of next-generation neurotechnology.
Compliance Strategy and the Role of Subject Matter Experts
Bringing a neurological device to market requires more than innovation – it takes a well-planned, adaptive compliance strategy. FDA reviewers expect:
- Clear evidence of safety, effectiveness, and usability
- Robust quality systems and a total product life cycle approach
- Alignment with current standards and guidance for non-clinical testing, such as software validation, cybersecurity, labeling, biocompatibility, and electrical safety
Given this complexity, engaging subject matter experts (SMEs) early can be critical. Experienced regulatory consultants help interpret FDA feedback, shape submission strategies, and anticipate potential challenges. Specialized regulatory knowledge in areas like software as a medical device (SaMD), AI/ML, and clinical trial design can streamline the path to clearance or approval.
RQM+’s Perspective
As neurological devices become more advanced and software-driven, FDA has evolved to provide more specialized, life cycle-focused oversight. This has opened the door for faster, safer innovation in neurology.
Our team has supported a wide range of manufacturers spanning early to mature stages on neurological devices ranging from implantables to AI-enabled platforms. We help companies navigate every phase of development – from regulatory strategy and FDA submissions to clinical trials, quality systems, laboratory services, reimbursement, and market access.
Companies that plan early, understand the regulatory landscape, and work with the right experts are best positioned to bring safe, effective, and transformative neurological devices to patients
Developing neurological devices in today’s complex regulatory environment requires more than technical excellence—it takes the right partner with deep FDA expertise and a proven track record. At RQM+, we specialize in helping MedTech companies accelerate progress while ensuring safety, compliance, and clinical impact. Let’s Make MedTech Happen. Contact us today to speak with a neurological device expert.
