Clinical Evaluation for SaMD

What is Clinical Evaluation for SaMD?

The FDA defines clinical evaluation for SaMD (Software as a Medical Device) as a set of ongoing activities conducted in the assessment and analysis of SaMD’s clinical safety, effectiveness and performance as intended by the manufacturer in the SaMD’s definition statement¹. Conducting a thorough clinical evaluation of a SaMD product is essential because the FDA requires clinical evidence for safety and efficacy before market approval. Clinical evaluation for SaMD consists of three key steps: establishing clinical association, analytical validation, and clinical validation.

The extent of clinical evaluation activities depends on the risk profile of the product. In 2017, the FDA released guidance on Software as a Medical Device (SaMD) Clinical Evaluation, outlining the clinical evidence requirements for SaMD products.

SaMD Clinical Association

Establishing clinical association is the first step in SaMD clinical evaluation. This step answers: Does the software’s output have a valid connection to real-world medical use? It verifies that the software’s intended function is medically meaningful and associated with a specific clinical condition. To establish clinical association, manufacturers can use various techniques including but not limited to:

Scientific evidence (e.g., published research, clinical studies)
Expert opinions from medical professionals
Professional society guidelines
Real-world data from existing patient cases

Establishing clinical association verifies the SaMD product is built on solid medical reasoning before proceeding to validation.

Analytical Validation

Analytical Validation is the second step in SaMD clinical evaluation. This step answers: Does the software function as expected across different conditions and use cases? It verifies the software accurately processes inputs and produces reliable, consistent outputs.

Manufacturers can conduct analytical validation using various testing techniques including but not limited to:

Precision:
Assesses the repeatability (consistency under the same conditions) and reproducibility (consistency under different conditions) of the software.
Accuracy:
Determines how closely the software’s outputs match the true or expected results.
Reliability:
Evaluates the software’s ability to perform its intended function under normal conditions and over time.
Sensitivity:
Measures the software’s ability to correctly identify true positive results.

Conducting appropriate analytical validation verifies that the software performs consistently and reliably prior to testing in real-world clinical settings.

Clinical Validation

Clinical Validation is the final step in SaMD clinical evaluation. This step answers: Does the software’s performance result in improved patient outcomes and/or support medical decisions effectively? Clinical validation confirms the software performs as intended in a real-world clinical setting and results in clinically meaningful outcomes. Clinical validation evidence can be gathered from but not limited to:

Prospective and/or retrospective clinical studies
Performance comparison against gold standards
Clinical usability

Clinical Validation is essential to demonstrate the software functions correctly and delivers meaningful benefits in clinical practice, supporting safe and informed medical decision-making.

Why Choose Innovenn for Clinical Evaluation of your SaMD Product?

At Innovenn, we bring extensive expertise in clinical evaluation for SaMD products. Our team understands the complex regulatory requirements set by the FDA and other health authorities and specializes in guiding you through each step of the evaluation process. From helping establish clinical associations and overseeing rigorous analytical validation to managing thorough clinical validation, we help verify that your SaMD product meets all necessary standards for safety, effectiveness, and performance. Choose Innovenn to streamline your clinical evaluation process. To learn more and speak to our subject matter experts, please contact us.

Contact an Expert

References:

https://www.fda.gov/media/100714/download

Where healthcare innovation intersects with improved patient outcomes

Contact Innovenn

Global reach from Wisconsin HQ. Serving clients in the US, EU, UK & Canada

6410 Enterprise Lane
Suite 230
Madison, WI 53719

608-203-9748

info@innovenn.com

Stay Informed

Sign Me Up