Insights

On October 21st, the U.S. Food and Drug Administration (FDA) released a draft guidance that, if finalized, will update the agency’s 2018 guidance on its Breakthrough Devices Program (the “Program”). In the draft guidance, the FDA announced that when reviewing the eligibility of medical devices for the Program, the agency will also consider whether a device will help address health care disparities and promote health equity. In other words, FDA intends to specifically consider whether a device may provide for more effective treatment or diagnosis in populations impacted by health and/or health care disparities when determining eligibility for breakthrough status.

On September 28, 2022, the Food and Drug Administration (FDA) issued Clinical Decision Support Software final guidance. The guidance clarifies the agency’s scope of oversight and regulation of clinical decision support software based on the definition of a device in the Federal Food, Drug, and Cosmetic Act (FD&C Act). It also describes the criteria used to assess whether software functions do not meet the definition of a device.

The U.S. Food and Drug Administration (FDA) has again postponed the enforcement of certain requirements under the Drug Supply Chain Security Act (DSCSA), this time by three years.