What is a Software as Medical Device (SaMD)?

According to 21 CFR 862 or 866, a SaMD is a software that has received FDA approval as a medical device or as a CLIA-waived device. A SaMD might contain digital tools like electronic health record systems that assist AME workflow procedures like reading patient reports or gaining access to electronic medical records, or mobile applications that allow data sharing.


SaMD – eligibility for software

SaMD includes software that satisfies all three requirements;

  1. It includes particular elements called for by regulatory bodies for safety and efficiency.
  2. In accordance with the necessary rules and regulations, it must undergo testing and certification by an approved agency.
  3. The producer must offer proof that they adhere to these rules.

In addition to reading, you can watch this blog about SaMD too!

The origin of SaMD

HIMSS (Healthcare Information and Management Systems Society) created the term SaMD in 2009. SaMD is a software component of a medical device or system, but it does not meet the criteria of an electronic health record (EHR). SaMD does not collect patient data or provide users access to their own medical information through the app itself. For example, SaMD could be an app that allows users to track their blood pressure over time.

Classifications of Software as a medical device

The IMDRF classified SaMD into three types based on the software’s complexity and potential risk to patients.

  • Type I SaMD is a low-risk software application that has a low probability of harming patients and performs simple functions like fitness tracking apps and apps for managing minor symptoms.
  • Type II SaMD is a moderate-risk software application that is more complex than Type I and has a higher probability of causing harm to the patient if it malfunctions, examples include clinical decision support software, and medical image analysis software.
  • Type III SaMD is a high-risk software application that is the most complex and has the highest probability of causing harm to the patient if it malfunctions, examples include software that controls medical devices and software used for the diagnosis or treatment of serious medical conditions.

SaMD Classifications

It’s important to note that regulatory agencies may have different classification systems for SaMD, but the IMDRF classification is widely recognized.

Expected growth of SaMD

In the upcoming years, the rise of SaMD would continue to pick up speed. From 2021 to 2028, it may expand at a compound annual growth rate (CAGR) of 25.6%. The expanding acceptance of mobile health (mHealth) solutions, the prevalence of chronic illnesses, and the demand for affordable healthcare solutions are some of the drivers that are fueling this rise.

The COVID-19 pandemic contributed to the rise of SaMD. The healthcare sector turned to telemedicine and distant care to lower the risk of infection transmission. The ability to remotely monitor patient health and deliver prompt treatments makes SaMD technologies well-suited for remote care.

Technological improvements, rising patient demand for individualized, patient-centered care, and the need for affordable, effective healthcare solutions will all contribute to the expansion of SaMD. Regulatory difficulties and worries over data privacy are two obstacles, though.

How can I get a software license from the US Food and Drug Administration (FDA)?

The good news for US-based developers is that obtaining a software license from the FDA is not too difficult. What you must do is as follows:

  • Become a maker of electronic medical devices (EMDM). You can do this by submitting a registration form online or by submitting Form FDA 2532a via the Medical Device Reports System of your state (MDR). You should register as soon as possible if your product is already on the market and patients or healthcare professionals are using your product so that no one unintentionally uses it without the FDA’s official permission
  • If your product does not already have an ID number assigned by the FDA, request one.

What documents do I need to apply for a software license from the FDA?

Depending on the kind of medical device you will use with your software, you will require different documentation to apply for a software license with the FDA. For instance, if it’s an implanted device, you’ll need to include details on its design, operation, and safety and efficacy information. You simply need to submit information on the device’s design and function if it’s not an implanted device and doesn’t need pre-market clearance or notice.

Who can apply for a software license from the FDA?

It depends on your circumstances. Small businesses without venture money or other support will very certainly have to submit their licensing applications. If this is not the case and you have access to grants or investments, some businesses can speed up the procedure by doing all of the paperwork and research for you.

Be sure the agency is reliable if you decide to use them rather than doing it yourself. Several frauds out there take advantage of folks who lack knowledge or free time.

How long does it take to get a medical device license?

The FDA issues medical device licenses, which are necessary to commercialize your product in the US. The following factors affect how long it takes to obtain a medical device license:

  1. The kind of device you’re building. For e.g. a Class II medical device is easier to acquire an IDE than a Class III
  2. The advanced clinical study design suggested
  3. Regardless of whether you have previous expertise managing clinical studies utilizing comparable devices or technology

What if my software is considered as SaMD but doesn’t have a software license from the FDA?

If your software is classified as SaMD, but you don’t have a software license from the FDA, you must stop selling it right once to avoid legal repercussions. Before enforcement begins, there could be a grace period. But this can only be ascertained by communicating with the FDA directly.

As SaMDs are considered medical devices, the FDA must authorize their use in customary clinical procedures. You must submit a premarket approval (PMA) application to obtain permission for your SaMD. Your application must contain details about how you created the device and why it is secure and efficient. These data will be examined by the FDA before a decision is made about the approval of your product.


We hope you found this article helpful and informative. Keep an eye on this blog post as we will keep adding more information related to SaMD. For any inquiries, feel free to contact us.