A Review on Software as Medical Devices (SaMD) as per USFDA

Medical devices and medical software; Depending on its intended function or indication for usage, the term "software" can refer to any software, software item, or system used in a medical environment. Although software plays an increasingly essential role in medical devices, particularly in mobile healthcare, the rapid growth of these technologies, particularly standalone software, continues and mobile technology poses challenging new issues for regulatory bodies worldwide. There is currently a dearth of criteria that would enable member economies to determine the proper degree of software controls and promote a uniform approach to regulate among member nations. There are currently insufficient regulations to enable member economies to decide on the appropriate degree of software controls and to promote a consistent regulatory approach across member countries. Medical software regulatory organizations have been established and put into operation. They act as an environmental scan, offering advice on the rules for a suggested regulatory framework that is based on best practices and can be adopted. To establish SaMD safety, efficacy, and performance, the International Medical Device Regulators Forum (IMDRF) aims to provide a shared knowledge of clinical evaluation and criteria.

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Authors

DROMA H. PATEL; Kalpana Patel; Sakshi Satya

Published

Aug 26, 2026

Journal or venue

Journal of Regulatory Science

DOI

10.21423/jrs.regsci.141315

Paper type

journal article

Source

Crossref