When software is developed for a specific medical purpose, companies need to determine whether it falls under U.S. Food and Drug Administration (FDA) medical device regulations. FDA Software as a Medical Device Guidance helps developers understand how software functions may be evaluated and what regulatory considerations may apply. “Software as a Medical Device (SaMD)” is a term commonly used for software that performs a medical function without being built into a physical medical device.
For FDA purposes, the regulatory status of software depends on what it is intended to do, how it works, who uses it, and the potential risks associated with its use.
What Is Software as a Medical Device?
SaMD refers to software that can perform a medical function on its own rather than serving only as part of a physical medical device. Some common examples include software that:
- Reviews and analyzes medical images
- Helps identify possible diseases
- Tracks or monitors health conditions
- Calculates clinical measurements
- Supports diagnostic decisions
- Provides information that may assist treatment
- Analyzes patient or clinical data
However, being used in a healthcare setting does not automatically mean that software is regulated by the FDA. For example, a basic wellness application that records daily activity may have different regulatory requirements from software designed to identify signs of a disease.
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This is why developers should clearly establish the intended use of their software before making regulatory decisions. FDA Software as a Medical Device Guidance can help developers understand the regulatory considerations associated with different software functions.
Key FDA Guidance for Medical Device Software
The FDA’s Content of Premarket Submissions for Device Software Functions, finalized in June 2023, provides guidance on the software-related information manufacturers may need to provide during a premarket review. It helps developers understand what technical and development details can be relevant when the FDA evaluates the safety and performance of medical device software.
The type and amount of information needed can vary depending on the product and its risk level. As part of FDA Software as a Medical Device Guidance, developers should consider areas such as:
| Area | What Developers Should Address |
| Intended use | Explain the medical purpose, users, and conditions involved |
| Software functionality | Describe what the software does and how users operate it |
| Requirements | Define expected functions and performance |
| Architecture | Explain the main software components and how they connect |
| Risk management | Identify possible hazards and measures used to control them |
| Verification | Show that the software meets its specified requirements |
| Validation | Demonstrate that the software works as intended |
| Testing | Document testing methods, results, and significant findings |
| Cybersecurity | Identify security risks and safeguards |
| Software anomalies | Record known unresolved issues and their potential impact |
| Version control | Keep track of releases, modifications, and updates |
Much of this information should come from the normal software development and testing process rather than being created only for an FDA submission.
How Does the FDA Determine Whether Software Is Regulated?
The FDA does not treat every healthcare software product as a medical device. Developers need to look closely at the software’s specific purpose and functions. Before deciding on a regulatory strategy, developers should ask:
- What is the software’s intended medical purpose?
- What functions does the software perform?
- Who will use the software?
- What type of information does it process?
- Could its output influence diagnosis or treatment?
- What risks could result from incorrect or incomplete outputs?
Understanding these factors is an important part of applying FDA Software as a Medical Device Guidance to a specific product.
Clinical Decision-Support Software
Clinical decision-support (CDS) software requires careful assessment because certain CDS functions may not be considered medical devices when they meet specific legal requirements.
The FDA’s Clinical Decision Support Software guidance, issued in January 2026, explains how certain CDS functions may qualify for exclusion from the medical device definition. It also clarifies that software functions that do meet the definition of a medical device can remain subject to FDA requirements.
When evaluating CDS software, developers should look at:
- What information the software provides
- How that information is generated
- Who will use the software
- Whether healthcare professionals can independently review the information
- Whether the software gives recommendations or conclusions
- How the software’s output could affect patient care
These considerations should be evaluated alongside the broader principles described in FDA Software as a Medical Device Guidance.
Cybersecurity Requirements
Cybersecurity should be considered from the early stages of medical software development. This is especially important when software connects with hospital networks, cloud platforms, electronic health records, or other medical devices.
The FDA‘s cybersecurity guidance provides recommendations for secure device development, labeling, and cybersecurity information that may be included in premarket submissions. Developers should pay attention to areas such as:
- Threat modelling
- User authentication
- Access controls
- Data protection
- Security testing
- Vulnerability management
- Secure software updates
- Incident response
- Software Bill of Materials (SBOM) security
Security should be part of the development process, not something addressed just before an FDA submission. This approach also supports the documentation and risk-management expectations relevant to FDA Software as a Medical Device Guidance.
FDA Regulatory Pathways
| Pathway | General Purpose |
| 510(k) | Used to demonstrate that a device is substantially equivalent to an appropriate legally marketed device |
| De Novo | Available for certain novel devices that do not have a suitable predicate |
| PMA | Used for certain higher-risk Class III devices that require a detailed review of safety and effectiveness |
| IDE | May apply when a medical device is being evaluated in a clinical investigation |
| HDE | Applies to certain devices intended for humanitarian use that meet FDA requirements |
The correct pathway depends on the software’s intended use, risk level, classification, technology, and whether an appropriate predicate device is available. Developers should assess these factors carefully rather than assuming that one pathway applies to all software products.
Steps for FDA SaMD Preparation
Developers can approach FDA preparation through the following steps:
- Define the intended use and medical purpose.
- Determine whether the software falls within the medical device definition.
- Assess the likely device classification and regulatory pathway.
- Document software requirements and specifications.
- Identify potential risks and establish appropriate controls.
- Develop and test the software.
- Carry out verification and validation activities.
- Identify and address cybersecurity risks.
- Prepare the relevant regulatory documentation.
- Keep records of software changes, releases, and updates.
Following these steps can help organize the regulatory process and support the documentation principles associated with FDA Software as a Medical Device Guidance.
Common Challenges
Medical software companies can face regulatory problems when compliance planning begins too late. Some common challenges include:
- An unclear intended use
- Incomplete risk assessment
- Limited software testing
- Poor technical documentation
- Weak links between requirements and test results
- Cybersecurity weaknesses
- Poor change management
- Selecting an unsuitable regulatory pathway
Addressing these issues early can reduce delays and help developers build regulatory considerations into the software lifecycle.
Also Read: Exploring enterprise-level analytics in medical software solutions
Conclusion
FDA requirements for Software as a Medical Device depend on several factors, including the software’s intended purpose, functionality, risk, and classification. There is no single regulatory checklist that applies to every medical software product.
A practical approach is to consider regulatory needs throughout the entire software lifecycle. Clear requirements, risk assessment, testing, validation, cybersecurity, and proper documentation should be part of development from the start. By applying FDA Software as a Medical Device Guidance throughout the development process, companies can better organize their regulatory strategy and prepare appropriate documentation.
Frequently Asked Questions
1. Is all healthcare software regulated by the FDA?
No. FDA oversight depends on the software’s intended use and functionality. Software used in healthcare does not automatically qualify as a regulated medical device.
2. Does every medical software product need FDA approval?
When FDA oversight does apply, the appropriate pathway may include 510(k), De Novo, PMA, or another applicable process. The appropriate route depends on the product’s classification, intended use, risk, and other factors.
3. Does the FDA regulate AI-based medical software?
AI-based software may fall under FDA medical device regulations when it meets the applicable definition. The FDA has also developed guidance addressing AI-enabled device software and certain planned changes to these products.
4. Why is cybersecurity important for SaMD?
A cybersecurity weakness can affect software reliability, data security, and potentially patient safety. Developers should consider cybersecurity throughout the product lifecycle, including threat modelling, testing, vulnerability management, and secure updates.
5. Why is intended use important in FDA software regulation?
Intended use helps establish what the software is designed to accomplish and whether its functions may fall within the medical device definition. Developers should define intended use clearly before selecting a regulatory strategy.
Overall, FDA Software as a Medical Device Guidance should be considered alongside the specific FDA regulations and guidance documents applicable to the product. Developers can then determine whether FDA requirements apply, assess the likely classification and regulatory pathway, and identify the guidance relevant to their software.
