Stay updated with breaking news from Device Software Functions. Get real-time updates on events, politics, business, and more. Visit us for reliable news and exclusive interviews.
Food and Drug Administration FDA released Good Machine Learning Practice for Medical Device Development: Guiding Principles developed in conjunction with Health Canada and the United Kingdom UK Medicines and Healthcare products Regulatory Agency MHRA.
This article examines another major regulatory regime relevant to mHealth application developers – the Federal Food, Drug and Cosmetic Act (FDCA), as well as regulatory issues unique to...
This article examines another major regulatory regime relevant to mHealth application developers – the Federal Food, Drug and Cosmetic Act FDCA, as well as regulatory issues unique to non-US companies.
We will explore the history of FDA’s regulation of software-enabled medical devices and stand-alone software and the agency’s more recent progress with digital health policies.