Regulatory for Software as a medical device in the USA

Software as a Medical Device (SaMD) plays a pivotal role in healthcare worldwide, with its significance particularly pronounced in the United States. In an era increasingly reliant on digital solutions, SaMD offers innovative ways to diagnose, treat, and monitor health conditions, revolutionizing patient care.

Regulatory for Software as a medical device in the USA

The United States, being a global leader in technology and healthcare, stands at the forefront of SaMD development and adoption. The market for SaMD in the USA is robust, driven by factors such as a large patient population, advanced healthcare infrastructure, supportive regulatory framework, and significant investment in research and development.

Choosing the USA for SaMD endeavors offers numerous advantages. Its regulatory environment, overseen by the Food and Drug Administration (FDA), ensures safety and efficacy standards, instilling confidence in developers and end-users. 

Additionally, the USA provides a conducive ecosystem for innovation, with a wealth of talent, resources, and investment opportunities. Moreover, access to a diverse patient population and healthcare providers facilitates an ideal market for SaMD in the US.

This article provides valuable insights into the SaMD sector in the USA, offering a clear understanding of its importance and potential impact.

The market for SaMD in the USA

By 2034, projections suggest that the United States will command a significant share, approximately 24.3%, of the global market for SaMD. This anticipated dominance underscores the country’s pivotal role in driving innovation and adoption within the healthcare technology sector. 

  • In 2024, the United States is set to dominate the North American market with a projected share of 90.2%, maintaining its lead in the years ahead.
  • The advancement of medical technology in the United States is closely linked to AI progress, propelling further innovations.
  • Software designed for both medical and non-medical functions, such as financial and administrative tasks, has gained widespread adoption. 
  • This trend is mainly due to the accessibility of various technology platforms like smartphones, personal computers, and network servers, as well as the growing simplicity of access and distribution methods like the cloud and the Internet. 
  • Between 2020 and 2021, the FDA regulated over 19,000 firms manufacturing approximately 200,000 SaMD.
  • Spending on SaMD in the United States surged from US$ 36 billion to an estimated US$ 199 billion by 2019.
AttributeUnited States
Market valueUS$ 200 Million
Growth rate (2024-2034)13.5 % CAGR
Projected value (2034)US$ 700 Million

SaMD market in the USA from 2018–2028

The USA Software as a Medical Device (SaMD) market has exhibited steady growth since 2018, maintaining a robust Compound Annual Growth Rate (CAGR) of 13.5%. Projections suggest this upward trend will persist consistently until 2028, with the market expected to expand at the same CAGR. The accompanying chart vividly illustrates this sustained growth.

Software as a medical device market in the USA from 2018-2028

Market dynamics, opportunities and trends in the USA SaMD market

  1. SaMD usage in the USA has surged due to its convenience, cost-effectiveness, and ability to enhance patient care remotely.
  2. Regulatory bodies like the FDA have streamlined approval processes, encouraging innovation and driving market growth.
  3. AI, machine learning, and data analytics have empowered SaMD developers to create more effective solutions.
  4. SaMD telehealth platforms have facilitated remote monitoring and diagnosis, catering to the growing demand for virtual healthcare services.
  5. The burgeoning SaMD market has attracted numerous players, fostering competition and further innovation to meet evolving healthcare needs.

Challenges in the USA SaMD market and how to overcome them

The USA SaMD market offers many benefits, yet it also presents challenges. Here are some key challenges and ways to overcome them in a simplified table format:

ChallengesWays to overcome
Regulatory complianceEstablish a dedicated team for regulatory compliance and stay updated with regulations.
Data security concernsImplement robust cybersecurity measures and conduct regular security audits.
Interoperability issuesPrioritize interoperability standards and collaborate with stakeholders for seamless integration.
Reimbursement hurdlesAdvocate for favorable reimbursement policies, demonstrate economic value, and explore alternative payment models.
User acceptance and adoptionInvest in user-centered design, provide comprehensive training, and foster a culture of innovation.

Regulatory framework for SaMD in the USA

In the USA, SaMD is regulated by the Food and Drug Administration (FDA), which oversees the safety and effectiveness of medical devices, including software. The regulatory framework for SaMD includes various regulations and guidance documents.

Navigating FDA regulations can be complex, especially for SaMD developers. However, understanding the regulatory requirements and following best practices can streamline the approval. Developers should engage with the FDA early in the development process, maintain clear documentation, and conduct rigorous testing to ensure compliance with regulatory standards.

Curious about the worldwide regulatory landscape for SaMD? Click here to find out more.

FDA definition and classification for SaMD

The FDA has embraced the definition of the  Software as a Medical Device (SaMD), set forth by the International Medical Device Regulators Forum (IMDRF):

“Software intended to be used for medical purposes that perform these purposes without being part of a hardware medical device. “

The FDA regulates the SaMD using the standard medical device classifications. These classifications determine the level of risk associated with the device and the control measures required to ensure its safety and effectiveness.

Device classRisk levelRegulation
Class ILow riskRegulated by general FDA controls, often exempt from premarket approval.
Class IIModerate riskSubject to general and special controls, clearance typically via the FDA 510(k) pathway. May use the De Novo pathway if no suitable predicate exists.
Class IIIHigh riskSubject to general and special controls, rigorous premarket approval (PMA) is required, often based on clinical trial data.
Enforcement discretionLow riskFDA may exercise discretion in enforcing requirements under the FD&C Act for some low-risk software, as outlined in the policy for device software functions and mobile medical applications. Manufacturers should comply with medical device requirements.

Documentation requirements according to FDA

The FDA guides the documentation needed in a premarket submission for software products. This guidance outlines what information is necessary to assess the safety and effectiveness of the software. It categorizes concerns into three levels (minor, moderate, and major) based on the severity and likelihood of harm. Depending on the level of concern, different documentation requirements apply.

Software descriptionYesYesYes
Hazard analysisYesYesYes
Software requirementsYesYesYes
Software architectureNoYesYes
Software design specificationNoYesYes
Software development environment descriptionNoYesYes
Verification and validationShortYesYes
Traceability analysisYesYesYes

FDA approval pathways for SaMD

FDA approval pathways for Software as a Medical Device (SaMD) vary based on device classification and the presence of a predicate device. The pathways include:

  • 510(k) pathway- Applies to Class I devices without exemption and Class II devices with substantially equivalent predicates in the US.
  • Pre-market approval pathway- The strictest pathway. Requires more than general and special controls, often necessitating unique methodologies, such as clinical data from trials, to demonstrate safety and effectiveness.
  • The De Novo pathway- De Novo pathway, established in 1997, is for novel devices lacking predicate equivalents. In this pathway, general or special controls ensure safety and effectiveness.

FDA regulations on artificial intelligence

  • FDA defines artificial intelligence (AI) as technology mimicking human behavior, including machine learning, neural networks, and natural language processing.
  • More regulatory guidelines for AI in healthcare should be included.
  • Viz LVO software in 2018 obtained regulatory approval via the De Novo pathway, setting a precedent for future AI-based technologies.
  • In 2021, the FDA’s CDRH published the AI/ML software as a medical device action plan, recognizing the need for additional premarket reviews due to AI’s adaptive nature.
  • A draft guidance on marketing submission recommendations for AI/ML-enabled device software functions was published in April 2023, emphasizing iterative improvement and patient safety.

Future outlook and emerging trends in the USA SaMD market

Looking ahead, the future of SaMD in the USA is promising, with emerging trends such as:

  • Artificial intelligence
  • Telemedicine integration
  • Personalized healthcare solutions  

As technology continues to evolve, SaMD is poised to play an even more significant role in shaping the future of healthcare delivery.


In conclusion, the landscape of Software as a Medical Device (SaMD) in the USA offers immense opportunities for innovation and growth. By understanding the regulatory framework, navigating challenges, and leveraging market trends, SaMD developers can unlock the full potential of their products and contribute to improving patient outcomes and advancing healthcare delivery in the USA and beyond.

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