How Does FDA Classify Software As A Medical Device (SaMD)?

How Does FDA Classify Software As A Medical Device (SaMD)?


Nowadays almost all the facets of healthcare are well-equipped with the modern and latest technology tools, including software systems. The use of the software is fully incorporated into digital services for both medical and non-medical uses. One of three forms of software connected to medical devices is software that, on its own, qualifies as a medical device.

SaMD Software as a Medical Device

Software that is a part of a medical device (software in a medical device) and software used in the creation or upkeep of a medical device are the other two categories of software connected to medical devices. Due to this reason, FDA classifies software as a medical device (SaMD).

Let’s know about software as a medical device (SaMD) and why FDA classifies software as a medical device.

What is Software as a medical device (SaMD)?

Software is recognized as a medical device when it aids the healthcare system in a way that positively impacts one or two sectors or parts of the healthcare system without the usage of any hardware medical tools. This method demonstrates the benefits of using cutting-edge technological instruments that work as a software and don’t require any kind of physical setup.

The term Software as a Medical Device is very well defined and explained by the International Medical Device Regulators Forum (IMDRF) as “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.”

The use of software as a medical device is on the rise, and we can see and comprehend the advantages it offers, particularly in emergencies or when patients want quick assistance. It can be applied to a wide variety of online activities, including VLANs, medical device operating systems, and industrial “off-the-shelf” platforms, to name a few. Previously, such software was regarded as “single-player software,” “healthcare industry software,” and/or “health operating systems” by businesses, global authorities, and healthcare professionals.

Why has the FDA classified Software as a Medical Device (SaMD)?

It is no secret that many nations throughout the world are still unaware of the enormous and significant benefits linked to the use of software for healthcare systems. Because of this, there is a need to raise public knowledge of its significance, importance, and overall influence of it on the healthcare system. The benefits of this software need to be made clear to the general public because they go well beyond those of conventional medical equipment. Harmonizing medical device regulations will be made easier with an understanding of these facts. FDA has classified software as a medical device to observe even further benefits of it in the future. IMDRF develops internationally agreed-upon documents related to a wide variety of topics affecting medical devices. In 2013, IMDRF formed the Software as a Medical Device Working Group (WG) to develop guidance supporting innovation and timely access to safe and effective SaMD globally.


Seeking Medical Device 510K or Software as a Medical Device (SaMD) Registration & Licensing?

How to know if your product is a part of the FDA? 

The definitions of Software as a Medical Device (SaMD) provided by IMDRF, and the FDA are essentially the same. It is also another supporting information that the FDA is also a member of IMDRF so when your product is approved by FDA, your software product can achieve the status of SaMD.

Firstly, it is important to know the quality of your product and whether it has the potential to be regarded as a medical device. The quality and the ability of the intended product can easily be evaluated in the light of the definition by IMDRF which says, “intended for one or more medical purposes”. FDA cites the FD&C act’s section 181(h) definition of a device, which reads as follows:

An item that is a tool, machine, implement, implant, contraption, in vitro reagent, or another similar or related item, including a component or accessory.

It must be:

  • recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
  • intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
  • intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.

Note: The term “device” does not include software functions excluded according to section 520(o).

Here it is worth mentioning that the term “intended use” refers to the actual use for which that particular software is designed and which particular problem it will address as a medical device.

How does SaMD qualify for 510k Registration?

The FDA is the regulatory body that sets out the standards for medical device registration. It reviews and approves any new medical device before it can be sold in the United States. The FDA is responsible for ensuring that these devices are safe and effective, as well as meeting certain requirements set out by law. A 510(k) clearance refers to a notification of a substantially equivalent device to an already cleared device. This notification allows the company to market its product without additional testing, providing that they abide by certain conditions set out by the FDA.

Final Verdict

Regulations and guidelines for SaMD still contain some ambiguities that will need to be clarified in the upcoming years. Concerning issues like cybersecurity, there is still considerable work to be done. The learning curve for software professionals transitioning into the medical device industry is very significant.

But this area also offers tremendous possibilities and excitement. We want you to reduce the effort required to create reliable software for medical devices by acquiring licenses so that your business can thrive through compliance and risk mitigation.

There is no reason why your organization can’t produce high-quality SaMD that enhances the quality of life for millions of patients with the appropriate tools and the finest available expert advice. One helpful platform in this regard is Quality Smart Solutions.

The time has arrived for you to realize your goal of having your software authorized as a medical device.

Need more information or want to know the SaMD licensing procedure?

How Quality Smart Solutions can help

Our experts at Quality Smart Solutions are here to help and offer medical device-related regulatory advice and support on successfully securing your medical device license.  We can help you by responding to potential information requests, keeping your license updated, and reviewing your device labels. 

Contact us today to learn more about how we can support your compliance needs during and after licensing! Please find our contact information here: 

30 Minute Free Consultation
0/5 (0 Reviews)
This website uses cookies to provide necessary site functionality and improve your online experience. By using this website, you agree to the use of cookies as outlined in Quality Smart Solutions's online privacy statement.