May 29, 2018
“The FDA is adapting our regulatory approach to digital health technologies to accommodate the highly iterative nature of these tools. Our aim is to make sure that safe and effective advances can be made available to patients more efficiently,” said FDA Commissioner Scott Gottlieb, M.D. “As part of this process, we’re committed to soliciting feedback on our approach. In keeping with our mandate from Congress, we’re also committed to reporting on the impact of software functions that current law excludes from FDA regulation, such as general wellness software functions. Today’s effort is part of our work to obtain public input that will help shape our report to Congress about these software functions that we don’t regulate.”
Today, the FDA is opening a docket to solicit feedback on important provisions of the 21st Century Cures Act (“Cures Act”). The Cures Act amended the Federal Food, Drug, and Cosmetic Act to exclude certain medical software functions from the definition of a medical device. Under the Cures Act, Congress excluded specific types of software from FDA regulation, including general wellness software products, electronic patient records and more.
As required under section 3060(b) of the Cures Act, the FDA is examining information on these non-device software functions and assessing the impact that such software functions have on patient safety; including best practices to promote safety, education and user competency related to such functions. The agency will publish its findings and issue a report later this year regarding the benefits and risks of these functions.
As part of that effort, the FDA has opened a docket to request public input on benefits and risks to health associated with the software functions excluded from the device definition by the Cures Act. The FDA will incorporate this input as the agency develops its report on these functions.
Comments may be submitted to the public docket here. Please submit comments for consideration in the development of the report by June 28, 2018.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.