FDA
The Food and Drug Administration (FDA) issued guidance dedicated to the digital health devices used to treat psychiatric disorders in the context of the outbreak of the Coronavirus Disease 2019 (COVID-19) caused by the virus “SARS-CoV-2” or the “novel coronavirus” and...
North America
Pre-cert Program, or also known as the Software Precertification Pilot Program (Pre-Cert), was first mentioned in the FDA’s Digital Health Innovation Action Plan. The purpose of this pilot program is to create a foundation for digital health regulation that is able to...
North America
Mobile health app The growing significance of mobile health apps result in a need to ensure its proper regulation. Practitioners, patients, researchers and medical industries are all affected by mHealth apps. The digital health field is regulated by the FDA under four...
