Page 2 - Device Software Functions News Today

This first part of a two-part series on U.S. regulation of artificial intelligence systems provides an overview and modern context for the existing regulatory, legal and risk management...

FDA has recently published two much-anticipated items related to artificial intelligence (“AI”), one pertaining to medical devices and the other to drug manufacturing. FDA has cleared...

We are pleased to present the first issue of our newsletter analyzing recent trends and developments impacting the life sciences industry, including DOJ policy updates and key...

Medtech companies are evolving rapidly as more and more of them develop products that collect and leverage substantial patient and provider data. ​​​​​​​ Companies that...

On April 18, 2023, the U.S. Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) published a far-reaching proposed...

Femtech (female health technology) has made significant progress toward bringing women’s health to the forefront of medical attention. However,...

The US Food and Drug Administration (FDA or the Agency) recently issued its draft guidance titled “Marketing Submission Recommendations for a Predetermined Change Control Plan for...

The U.S. Food and Drug Administration (FDA) is continuing its effort to provide industries with updated guidance for digital health technologies. On April 3, 2023, the FDA released...

On April 3, 2023, the US Food and Drug Administration (FDA) published its draft guidance, Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial...

On April 3, 2023, the Food and Drug Administration (FDA) published in the Federal Register an announcement of availability for the draft guidance, Marketing Submission Recommendations...