Akin Gump Health Care Lawyers Pen FDA Software Guidance Article for Law360

Law360 has published “Noteworthy Changes From FDA's Latest Software Guidance,” an article by Akin Gump health care and life sciences partners Nathan Brown and Howard Sklamberg, senior counsel Matthew Wetzel, counsel Christin Carey and associate Marlee Gallant.

The article discusses six pieces of software-related guidance recently released by the U.S. Food and Drug Administration (FDA) in furtherance of the agency’s Digital Health Innovation Action Plan:

• Clinical Decision Support Software
• Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act
• Policy for Device Software Functions and Mobile Medical Applications
• General Wellness: Policy for Low-Risk Devices
• Off-The-Shelf Software Use in Medical Devices
• Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices.

The authors note that the guidance makes a number of technical changes and clarifications to the FDA’s interpretation of the 21st Century Cures Act, which amended the Food, Drug and Cosmetic Act by defining “five categories of software functions to which the statutory definition of a ‘device’ in section 201(h) does not apply, including Clinical Decision Support (CDS).

In this article, they take an in-depth look at the CDS guidance and summarize noteworthy changes in the five other guidance documents.

To read the full article, click here.