Over the two-part series, I will explain why the FDA Leap Frog guidance is relevant and provide a practical summary of what’s inside. Part 2 found here.

From classics such as The Matrix to the recent efforts of Elon Musk, Brain Computer Interfaces (BCIs) have been heralded as a transformative technology that will ultimately revolutionize how we relate to the world around us.

My first exposure to BCIs was in the early 2000’s at a talk from professor Kevin Warwick, a self-proclaimed cyborg who underwent invasive surgery to integrate himself with the technology around him. From controlling a fifth limb via thought to directly communicating with his wife’s nervous system, his Sci-Fi inspired experiments powered by implanted Utah Arrays and microchips were a precursor to many of the trends in BCI development today.

Despite significant advancements since Warwick’s early 2000’s experiments, implanted BCIs are still largely confined to academic labs and single patient trials. Because these breakthrough technologies do not yet meet the standards required by regulators, BCI products are not generally available to the public beyond a few notable exceptions such as cochlear implants and Deep Brain Stimulation (DBS) devices.

What is the regulators role in BCI technology?

To understand this deficit in commercially available neurotechnology, it’s important to understand the role regulators play in the clinical testing and release of medical devices, including BCIs. Regulators (e.g. the Food and Drug Administration (FDA) in the US or European Medicines Agency (EMA) in the EU) review products that make medical claims on behalf of consumers to ensure they are safe and effective before use.

In short, regulators determine when medical products will be trialled and eventually released to impact the lives of those around us. If you’re excited about NeuroTech and want to see BCI technology deliver on its futuristic promise, then a sense of familiarity with regulatory standards is key.

Those seeking to work on, invest in, or build medical BCIs without regulatory knowledge risk being overly optimistic about timelines or missing exciting opportunities for fear that regulatory approval is unachievable. Similarly, products developed without a clear understanding of regulatory requirements may encounter blind spots which need costly and time-consuming redevelopment to fix.

So what do regulators require?

The short answer is sufficient evidence of effectiveness and safety to justify the product’s use. Gathering this evidence, however, requires clinical trial data — a process which cannot begin without its own regulatory approval. In addition to this, gaining approval requires compliance with a myriad of regulations. Product developers can easily miss the mark, ultimately stalling progress or killing products completely.

The FDA eventually recognized that this impractical complexity was limiting availability of life changing technologies, so they decided to clear things up. After consulting industry leaders, the FDA released an official ‘Leapfrog Guidance’ document for BCIs in May 2021. This guidance focuses on clarifying a key point in the product development process: obtaining an Investigational Device Exemption (IDE). Once the IDE is obtained, BCIs can be used on real patients within the US and results gathered to support a larger trial or release of the product itself.

While the FDA only regulates the US market, the Leapfrog Guidance contains advice that is relevant to all. Since the US is the world’s largest healthcare market, gaining FDA approval will be a key milestone on most product road maps. The FDA also supports the use of many internationally recognized standards, simplifying compliance with regulators everywhere.

Although the Leapfrog Guidance specifically tackles implanted brain computer interfaces for patients with paralysis or amputation (the full name being ‘Implanted Brain-Computer Interface (BCI) Devices for Patients with Paralysis or Amputation — Non-clinical Testing and Clinical Considerations’), the framework laid out is applicable to almost all BCIs. The only difference is that the work required to prove safety for a non-invasive device can be significantly lower, as implantation is generally seen as riskier.

While the Leapfrog Guidance on BCIs provides clarity on much of the pathway to regulatory approval, it is still 41 pages long and contains many references to additional formal documents and processes. To simplify things, I’ll be breaking the FDA Guidance down in this two-part series and summarizing 9 key areas the document covers:

1. Device description — what is being designed and made
2. Managing risk — measures to ensure patient safety
3. Software development — creating software that is safe and effective
4. Potential misuse — avoiding unexpected outcomes
5. Biological harm — testing for safety at the cellular level
6. Electromagnetic safety and concerns — functionality in the real world
7. Bench testing — does the system perform as expected?
8. Non-clinical Animal testing — safety and reliability testing ‘in-vivo’
9. Clinical trial design — measuring the impact on patients’ lives

My hope is that after reading this series, you’ll not only be making your own informed judgments of Musk’s Neuralink related claims, but also be ready to critically assess your own product roadmaps, and avoid blind spots before they arise.

Continue to part 2 here.

Written by Jonathan Casey, edited by Avinash Royyuru, Emily Dinh, and Chelsea Lord, with artwork also by Chelsea Lord.

Jonathan’s work applies principles from engineering and product development to broaden access to technological innovations. He has worked extensively on the development of new medical devices and scientific instrumentation with a special interest in multidisciplinary projects where biological and artificial systems are combined to solve a genuine need.

Avinash is a freelance product manager writing a SciFi novel about merging brains.

Emily is a clinical trials researcher and data scientist. She is currently attending the University of San Diego for her MS in Artificial Intelligence.

Chelsea works in clinical operations and is currently working for a company that is a leader in brain-computer interfaces. She studied neuroscience and is interested in the AI and Machine-Learning side of neurotechnology.