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Medical devices have advanced beyond the point of simple machinery. Software has begun playing an important role in medical devices and also as stand-alone medical devices. Software as a Medical Device, or SaMD for short, is defined as “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.”[1] This is software designed with the express purpose of serving as its own medical device. The software could be a computer program that could be installed on any ordinary computer or it could be extremely complex and need to be paired with specialty equipment. This is different than Software in a Medical Device, SiMD, which can only exist within the actual physical device itself.

Health Canada, the FDA, and the UKs MHRA have set Good Machine Learning Practices (GMLPs) for SaMDs.[2] Similar to Good Manufacturing Practices, GMPs, GMLPs are designed to promote safety and quality in highly advanced software, like AI. There are a total of ten guiding principles for GMLPs set collaboratively between the regulatory bodies.2 As software continues to advance and the world becomes more connected the need for GMLPs will also grow. However, GLMPs are not the only regulations SaMDs are subject to.

SaMD is a medical device, which means under the FDA and other regulatory bodies they are still subject to medical device regulations, just the same as a physical device. This means that a SaMD will still need to go through the approval process of the FDA or any other applicable regulatory body. For the FDA this might mean the SaMD needs premarket approval, a 510(K), or another pathway depending on what class level of device the software falls under. Less complicated SaMDs may even be 510(K) exempt.

Getting a physical device approved can be a challenge in and of itself, a SaMD can be even more so. EMMA International’s team of experts can help ensure your SaMD meets all required regulations and achieves approval in whichever market you are attempting to sell. From ensuring all necessary quality systems are in place to helping file approval submissions EMMA International does it all. EMMA International can help innovation reach reality, give us a call at 248-987-4497 or email info@emmainternational.com to get in touch with our team of experts today.


[1] FDA (December 2018) Software as a Medical Device (SaMD), Retrieved 11/13/2021 from https://www.fda.gov/medical-devices/digital-health-center-excellence/software-medical-device-samd

[2] FDA (October 2021) Good Machine Learning Practices for Medical Device Development: Guiding Principals, Retrieved 11/13/2021 from https://www.fda.gov/medical-devices/software-medical-device-samd/good-machine-learning-practice-medical-device-development-guiding-principles

Gabe Kadoo

Gabe Kadoo

Mr. Kadoo is a Quality Engineer at EMMA International. He has experience in statistical analysis, performance improvement, quality assurance, and value stream mapping in the clinical setting. Mr. Kadoo also has experience as a clinical researcher and medical technologist. Mr. Kadoo holds a Bachelor of Science in Biology and a Master of Public Administration with a concentration in Healthcare Administration. He is also a Six Sigma Green Belt.

More Resources

De Novo Classification

De Novo Classification

A device can be registered for the De Novo pathway if there is evidence of the safety and effectiveness of the device and there is not a previously legally marketed predicate device1. When determining if your device can go through the De Novo process there are two pathways available to determine the device classification.
Abbreviated 510k submission

Abbreviated 510k submission

There are three types of 510K, Premarket Notifications, which can be submitted to the Food and Drug Administration (FDA) traditional, abbreviated, and special. Abbreviated and Special 510K submissions can be utilized when the submissions meet the certain factors presented by the FDA. When submitting an abbreviated 510K the submission must include the elements that are identified in 21CFR 807.87 for the information required in a premarket notification submission.
Is your product a medical device?

Is your product a medical device?

Many marketed products are classified as medical devices and you would not even know it. Medical devices range from latex gloves and tongue depressors to respirators and heart valves. To determine if the product is considered a medical device by the Food and Drug Administration (FDA) you will need to analyze if your product meets the definition of a medical device per the Food, Drug, and Cosmetic Act1.

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