Hold the Phone: FDA to Regulate Smart Phone Health Applications

International Journal of ChemTech Research

article

M. P. Venkatesh¹  Akash Dambal¹  Manish Kumar¹  T.M. Pramod Kumar¹ 

[1] School of Mechanical Engineering ,(SMEC) VIT University

关键词: Mobile apps;    FDA;    regulations;    smart phone;    medical devices;    data systems;   

DOI  :  10.20902/IJCTR.2018.110211

学科分类：农业科学（综合）

来源: Sphinx Knowledge House

【 摘 要 】

As mobile platforms become more user friendly, computationally powerful, andreadily available, innovators have begun to develop mobile apps of increasing complexity toleverage the portability mobile platforms can offer. Some of these new mobile apps arespecifically targeted to assisting individuals in their own health and wellness management.Other mobile apps are targeted to healthcare providers as tools to improve and facilitate thedelivery of patient care. Although the FDA has not issued an overarching software policy, theAgency has formally classified certain types of software applications that meet the definitionof a device and, through classification, identified specific regulatory requirements that apply tothese devices and their manufacturers. These software devices include products that featureone or more software components, parts, or accessories (such as electrocardiographic (ECG)systems used to monitor cardiac rhythms), as well as devices that are composed solely ofsoftware (such as laboratory information management systems).

【 授权许可】

CC BY