App Store product pages will now display whether an app is a regulated medical device, Apple says in a new post on its developer website.
From the post: To provide additional transparency on the App Store, apps that are available in the European Union (EU)/European Economic Area (EEA), United Kingdom (UK), or United States (US), and that also meet either of the criteria listed below must indicate whether they’re regulated medical device with respect to each region’s regulatory authority or body responsible for the governance and compliance of medical devices.
Regulated medical device apps are used for a range of medical purposes, including diagnosis, prevention, monitoring, and treatment of diseases and physiological conditions. They may function on their own or by interfacing with medical device hardware. Apple says these apps may require registration or authorization from regulatory bodies such as the U.S. Food and Drug Administration (FDA). Learn more about regulated medical devices in the EU/EEA, in the UK, and in the US.
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