A Review of Biomedical Devices: Classification, Regulatory Guidelines, Human Factors, Software as a Medical Device, and Cybersecurity

Abstract

Biomedical devices provide a critical role in the healthcare system to positively impact patient well-being. This paper aims to provide the current classifications and subclassifications of hardware and software medical devices according to the Food and Drug Administration (FDA) guidelines. An overview of the FDA regulatory pathway for medical device development such as radiation-emitting electronic product verification, product classification database, Humanitarian Use Device (HUD), premarket approval, premarket notification and clearance, post-market surveillance, and reclassification is provided. Current advances and the advantages of implementing human factors engineering in biomedical device development to reduce the risk of user error, product recalls and effective safe use are discussed. This paper also provides a review of evolving topics such as the Internet of Things (IoT), software as medical devices, artificial intelligence (AI), machine learning (ML), mobile medical devices, and clinical decision software support systems. A comprehensive discussion of the first FDA-approved AI-medical device for the diagnosis of diabetic retinopathy is presented. Further, potential cybersecurity-related risks associated with software-driven AI/ML and IoT medical devices are discussed with an emphasis on government regulations. Futuristic trends in biomedical device development and their implications on patient care and the healthcare system are elucidated.

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