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Author: Dharma Kallur | Date: September 21, 2023
Advancements in technology play a significant role in the medical device industry, especially regarding software. Software is integrated into many medical device products, but it can also be a medical device on its own. As with any medical device sold in the United States, software as a medical device (SaMD) is subject to regulation by the U.S. Food and Drug Administration (FDA), the governing body for medical device approval.
In the summer of 2023, the FDA released updated guidance on the content of premarket submissions for device software functions. Providing a clear outline of medical device regulations as they relate to SaMD, these updates come at a pivotal time in the medical device industry.
The International Medical Device Regulators Forum (IMDRF), a voluntary group of medical device regulators from around the world whose goal is to reach a consensus on medical device regulation, defines software as a medical device as “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.” SaMD is a distinctive category within the medical software realm, not to be confused with software applications that are integrated into a medical device and used in its manufacture or maintenance. These integrated applications are not considered SaMD.
Examples of software as a medical device include software that enables a smartphone to view images from a magnetic resonance imaging (MRI) for diagnostic purposes or Computer-Aided Detection (CAD) software that performs image post-processing to help detect breast cancer. Some SaMD uses artificial intelligence (AI), a technology that mimics human activity, decision-making, and learning, as well as machine learning, an AI technique used to design and train software to learn from and act on data.
Establishing federal regulations and approval processes is a time-consuming undertaking, and the FDA often struggles to match the pace of its regulations with technological advancement. As regulators establish medical device software requirements, technology is still rapidly emerging, making the task a moving target. Currently, the following guidance exists in the software as a medical device field:
At Sterling Medical Devices, we partner with businesses of all sizes—from small startups to leading medical device organizations—to design innovative medical devices with successful FDA/CE submissions. Our regulatory experts continually monitor the software as a medical device landscape, along with relevant guidance, standards, regulations, and best practices in the U.S. and abroad. To learn more about how we can help you achieve exceptional results with your medical device system development, contact us here.
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