Insights

What is Software as a Medical Device (SaMD)?

According to the International Medical Device Regulators Forum (IMDRF), SaMD is software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.

That means your software doesn’t have to be embedded in a device like an MRI machine or wearable ECG—if it independently serves a medical function, it’s considered SaMD.

Examples include:

• AI algorithms for image analysis

• Mobile apps for mental health monitoring

• Clinical decision support tools

• Virtual therapy platforms

👉 Read more about the FDA’s definition of SaMD here: FDA’s SaMD Page

Why is FDA Registration Important?

1. Patient Safety: FDA registration ensures your software complies with strict quality, safety, and performance standards. This is crucial, especially when your product is used to diagnose or influence treatment decisions.

2. Market Trust: Healthcare professionals and hospitals prefer FDA-cleared tools, as it confirms the product has been rigorously tested.

3. Legal Compliance: Skipping registration can result in regulatory action, fines, or being banned from the U.S. market.

4. Investor Confidence: FDA registration signals credibility to investors and stakeholders, often unlocking access to funding.

My Journey: Building and Registering a Neurological AI Assistant as SaMD

As someone deeply passionate about AI and healthcare, I had the opportunity to develop a neurological AI assistant designed to assist clinicians in early-stage diagnosis of neurodegenerative conditions such as Parkinson’s and early Alzheimer’s.

The Idea

The software—NeuroLens AI—was built to analyze multimodal inputs: speech patterns, facial micro-expressions, and hand tremor data collected via a smartphone app. Using advanced deep learning models, it could flag subtle signs often missed during manual evaluation.

The Development

We used:

• TensorFlow for our custom LSTM-based time-series model (for tremor signal analysis).

• OpenCV and MediaPipe for facial micro-expression capture and tracking.

• Natural Language Processing (NLP) models fine-tuned on clinical datasets for cognitive language analysis.

All processing was done on-device to protect patient privacy, with encrypted summaries sent to the cloud for clinician review.

The FDA Process

Getting NeuroLens AI registered as a Class II SaMD was no small feat. We had to:

• Conduct a Clinical Evaluation Report (CER) with pilot studies across 50 patients.

• Develop a Software Requirements Specification (SRS) and Software Design Description (SDD) per IEC 62304 standards.

• Create a robust Quality Management System (QMS) compliant with 21 CFR Part 820.

• Perform cybersecurity risk assessments and integrate continuous monitoring tools.

We submitted our 510(k) application with a predicate comparison, and after several months of back-and-forth, received FDA clearance.

It was a moment of validation—knowing that clinicians could now use NeuroLens AI as a reliable tool in early neurological assessments.

How to Start Your SaMD FDA Journey

If you’re developing medical software, here’s a step-by-step roadmap:

1. Determine SaMD Classification – Use the FDA Device Classification Panels to assess your software’s risk class.

2. Adopt a QMS Early – Start building your QMS around ISO 13485 and IEC 62304 from the beginning.

3. Collect Clinical Evidence – Consider pilot studies or retrospective analysis based on your software’s function.

4. Engage the FDA Early – Use the Q-Submission Program to ask questions before formal submission.

5. Submit the Right Application Type – 510(k), De Novo, or PMA, depending on your software’s risk and novelty.

Final Thoughts

In the rapidly expanding world of digital health, SaMDs hold enormous potential to democratize care and improve outcomes. But with that power comes responsibility—to patients, to clinicians, and to regulatory bodies.

Registering with the FDA isn’t just a checkbox. It’s a commitment to clinical integrity, safety, and trust.

As someone who’s walked this road, I can say: the process is intense but worth it. Not just for market access—but for the lives it can change.