Recently, the Food and Drug Administration issued a draft guidance, “Content of Premarket Submissions for Device Software Functions,” to help industry understand what it should include.
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.