Common Issues in Defining the Intended Purpose of SaMD
Overview
Software as a Medical Device (SaMD) can support diagnosis, monitoring, screening, treatment decisions, and clinical management without being part of a physical medical device. However, before determining its regulatory classification, clinical evidence, or market authorization pathway, manufacturers need to clearly define one fundamental element: the intended purpose of the SaMD.
The intended purpose explains the overall medical objective of the software and how it is intended to support healthcare activities. If this purpose is vague, overly broad, or inconsistent across regulatory documents, it can create challenges during product development and regulatory review.
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What Is the Intended Purpose of SaMD?
The Intended Purpose of SaMD is a description of the overall medical objective for which the software is developed and intended to be used. It helps establish the software’s medical role and provides context for its regulatory and technical documentation.
The Intended Purpose may relate to:
- The medical objective or function of the software
- The clinical role of the software
- The type of information or output generated
- How the output supports healthcare professionals
- Whether the software supports diagnosis, monitoring, treatment, or clinical decision-making
It is important to clearly differentiate the Intended Purpose from the Indications for Use (IFU).
The Intended Purpose describes the overall medical objective of the software, while the Indications for Use specify who will use the software, which patients it is intended for, and under what clinical conditions it will be used.
Example:
Intended Purpose: Software helps doctors review medical images.
Indications for Use: Software is used by radiologists to help identify lung nodules in chest CT scans of adult patients.
Maintaining this distinction helps manufacturers clearly define the software’s overall medical objective while also specifying the particular users, patient population, and clinical circumstances covered by its use.
The intended purpose can influence SaMD classification, risk assessment, clinical evaluation, regulatory strategy, labeling, and market authorization requirements.
Common Issues in Defining the Intended Purpose of SaMD
1. Using Broad or Vague Language
One of the most common problems is defining the software’s purpose too broadly.
For example, stating that software is intended to “improve patient outcomes” does not clearly explain what the software does or how its output is used.
A stronger intended purpose describes the specific medical objective and the software’s role in supporting healthcare activities. The statement should be clear enough to help establish appropriate safety, performance, and clinical evidence requirements.
2. Confusing Intended Purpose With Product Features
Manufacturers sometimes describe software features instead of its medical purpose.
For example, saying that an application “uses artificial intelligence to analyze medical images” describes a technical capability, but it does not fully explain the medical objective.
The intended purpose should connect the technology to its clinical role and explain how the output is intended to support healthcare professionals.
3. Not Clearly Defining the Role of AI/ML
AI and machine learning are increasingly used in SaMD for medical image analysis and other healthcare applications. When AI/ML is part of the software, manufacturers should clearly define its specific role and avoid overstating its capabilities.
AI/ML functions should be described as supporting healthcare professionals rather than replacing clinical judgment, where that reflects the intended use of the software.
For example, if AI is used to identify areas of interest in medical images, the intended purpose should state that the software assists clinicians in reviewing those areas rather than suggesting that it independently diagnoses a disease.
This distinction is important when developing the intended purpose, clinical claims, risk management documentation, and supporting evidence.
4. Failing to Define the Intended User and Patient Population
The same software functionality can have different implications depending on who uses it and which patients it is intended for.
The intended user could be a physician, radiologist, laboratory professional, nurse, pharmacist, patient, caregiver, or another trained healthcare professional.
Similarly, manufacturers should clearly consider the relevant patient population, medical condition, and clinical setting.
For example, describing software simply as being intended for “patients” may be insufficient if it is actually intended for adults with a particular condition in a defined clinical environment.
The intended use should also be aligned with the population represented by the available clinical evidence.
5. Overstating Clinical Claims
Claims should be clear, realistic, and supported by appropriate evidence. Manufacturers should avoid statements that imply guaranteed performance or suggest that the software replaces clinical judgment.
For example:
Avoid: “The software diagnoses diseases automatically.”
Use: “The software assists healthcare professionals in identifying suspected abnormalities.”
The claims made for the software should accurately reflect its validated capabilities. Overstated claims can create inconsistencies between the intended purpose, clinical evaluation, risk management documentation, labeling, and marketing materials.
6. Inconsistency Across Regulatory Documents
The intended purpose should remain consistent throughout the product’s documentation.
Different descriptions may appear in:
- Product labeling
- Website content
- User manuals
- Clinical evaluation reports
- Risk management files
- Software documentation
- Regulatory submissions
- Marketing materials
Even small differences can create questions during regulatory review. A controlled and consistent intended purpose helps maintain alignment across technical and regulatory documentation.
7. Not Aligning the Intended Purpose With Risk Management
The Intended Purpose serves as an important foundation for risk management, clinical evaluation, cybersecurity activities, and software testing.
Risks and controls should be aligned with how the software is intended to be used and the role its output plays in healthcare.
For example, for software intended to help detect lung nodules, risks such as missed detections or incorrect detections should be identified, evaluated, and appropriately controlled.
The intended purpose therefore helps establish the context for identifying relevant hazards, evaluating risks, defining controls, and determining appropriate verification and validation activities.
8. Changing the Intended Purpose During Development
The intended purpose may evolve as software development progresses. However, significant changes should not be treated as simple wording changes.
A change in the intended patient population, clinical condition, intended user, or clinical decision supported by the software may affect risk classification, clinical evaluation, verification and validation activities, documentation, and the regulatory pathway.
Manufacturers should therefore establish the intended purpose early and control significant changes through an appropriate design and regulatory change process.
How to Define a Clear Intended Purpose for SaMD
A practical approach is to consider the following questions:
What? What medical objective does the software support?
Who? Who are the intended users?
For whom? Which patient population is covered by the Indications for Use?
Under what conditions? In what clinical environment and circumstances will the software be used?
How? How does the software output support healthcare professionals or a medical decision?
The answers should remain consistent across the product’s regulatory and technical documentation.
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Why Intended Purpose Matters for SaMD Regulatory Strategy
The intended purpose is not simply a statement used for marketing or product labeling. It can become a foundation for the wider regulatory strategy.
A clearly defined intended purpose can help manufacturers determine appropriate SaMD classification, clinical evidence, risk management, cybersecurity activities, software testing, documentation, and regulatory submission strategy.
For products intended for multiple markets, manufacturers should also evaluate whether the intended purpose, indications for use, terminology, and claims remain appropriate across different regulatory jurisdictions.
How Operon Strategist Can Help With SaMD Regulatory Compliance
Defining the intended purpose of SaMD can become challenging when software involves AI/ML, clinical decision support, patient monitoring, or multiple intended users.
Operon Strategist provides regulatory consulting and documentation support for medical device and SaMD manufacturers. Its services include:
- Intended purpose and claims review
- Indications for Use review
- AI/ML medical device regulatory guidance
Operon Strategist can help manufacturers align their intended purpose, indications for use, product claims, risk management, clinical evidence, and regulatory documentation for different markets.
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FAQ's
What is the intended purpose of SaMD?
The Intended Purpose describes the overall medical objective of Software as a Medical Device and explains the medical role the software is designed to perform.
What is the difference between Intended Purpose and Indications for Use?
The Intended Purpose describes the overall medical objective of the software. The Indications for Use specify the intended users, patient population, and clinical conditions under which the software is intended to be used.
How should AI/ML be described in the intended purpose of SaMD?
The role of AI/ML should be clearly defined without overstating its capabilities. Where appropriate, the software should be described as assisting healthcare professionals rather than replacing clinical judgment.
Why should SaMD claims be supported by evidence?
Claims should accurately reflect the software’s capabilities and available evidence. Unsupported claims or statements that imply guaranteed performance can create regulatory and clinical concerns.
How does Intended Purpose affect SaMD risk management?
The Intended Purpose provides important context for risk management. Risks and controls should be aligned with the software’s intended use. For example, software intended to detect lung nodules should consider risks such as missed or incorrect detections.