ABSTRACT

Software is revolutionizing how doctors practice medicine, customers control their health, and patients and providers interact. Software that can perform advanced medical functions— software as a medical device—is a game-changing innovation in digital health technology (SaMD). SaMD may diagnose ailments, prescribe medications, and offer clinical treatment recommendations. The US FDA, EU, and Australia TGA also specified general platforms. To overcome the challenges while interpreting software product fits into the Medical Device framework, IMDRF has developed different guidance including Risk based categorization to determine possible levels of premarket reviews, and real-world evidence (RWE). IMDRF plays a similar function in enabling the regulators to risk-stratify submissions and focus resources on products that pose the greatest risk to patient safety. While SaMD products are not new, there are many new players in the SaMD space to better regulate iterative devices. One of the key goals is to identify the excellence of the SaMD Regulatory paradigm regulation of these products will need to radically change to accommodate new SaMD manufacturers and the technology’s rapid evolution and to harness SaMD’s ability to capture RWD to create a collaborative, innovative SaMD community. This review aimed to describe the Regulatory and Technical aspects of the software as a medical device and regulatory transformation of digital health rapidly expanding regulations by different Health Authorities. Keywords: SaMD, IMDRF, Risk Categorization, ISO/IEC, Application Lifecycle Management, GDPR
Publication date: 01/02/2024

https://ijbpas.com/pdf/2024/February/MS_IJBPAS_2024_7756.pdf

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https://doi.org/10.31032/IJBPAS/2024/13.2.7756