Page 5 - Device Software Functions News Today

The draft report offers recommendations for stakeholders about using digital health hardware and software to gather information from remote trial participants.

This week in Washington: President Biden acknowledges that the Build Back Better Act might not pass Congress this year.

Upcoming Hearings/Markups - December 8 - House Agriculture Committee, Nutrition, Oversight, and Department Operations Subcommittee Hearing: “Review of USDA...

Recently, the Food and Drug Administration issued a draft guidance, “Content of Premarket Submissions for Device Software Functions,” to help industry understand what it should include...

Congress - House - House Passes Reconciliation Package - On Nov. 19, the House passed the $1.7 trillion reconciliation package with a vote of...

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.

Healthcare

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.