Mobile software categories software#
The Policy for Device Software Functions and Mobile Medical Applications Guidance, first issued in 2013 as "Mobile Medical Applications" (MMA guidance) and updated in 2015, 2019, and 2022, explains the agency's oversight of device software functions, including mobile medical apps, as devices and our focus only on the software that presents a greater risk to patients if it doesn't work as intended and on software that causes smartphones, computers, or other mobile platforms to impact the functionality or performance of traditional medical devices. The FDA also has a public health responsibility to oversee the safety and effectiveness of medical devices – including mobile medical apps. The FDA encourages the development of mobile medical apps (MMAs) that improve health care and provide consumers and health care professionals with valuable health information. Users include health care professionals, consumers, and patients. These tools are being adopted almost as quickly as they can be developed. Mobile apps can help people manage their own health and wellness, promote healthy living, and gain access to useful information when and where they need it. The term "software functions" includes mobile applications (apps). The FDA's policies are independent of the platform on which they might run, are function-specific, and apply across platforms. Software functions that meet the definition of a device may be deployed on mobile platforms, other general-purpose computing platforms, or in the function or control of a hardware device. The widespread adoption and use of software technologies is opening new and innovative ways to improve health and health care delivery.
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