By Published On: October 8, 2020Categories: Digital Health, Real World Studies, RWE

Recently, the U.S. Food and Drug Administration announced it is launching the Digital Health Center of Excellence within the Center for Devices and Radiological Health (CDRH). The launch of the Digital Health Center of Excellence is an important step in furthering the agency’s overarching dedication to the advancement of digital health technology, including mobile health devices, Software as a Medical Device (SaMD), wearables when used as a medical device, and technologies used to study medical products.

The Digital Health Center of Excellence is committed to strategically advancing science and evidence for digital health technologies within the framework of the FDA’s regulatory and oversight role. While there are many aspects of the Digital Health Center of Excellence that are still under development, ultimately the goal is to empower digital health stakeholders to advance health care by fostering responsible and high-quality digital health innovation

>>>Learn more…

About the Author: stuart.mccully

Stuart is the founder of Phoenix-RWR (www.phoenix-rwr.co.uk) and has 15+ years experience providing regulatory compliance solutions for real world studies, such as non-interventional studies. Stuart is best known for his 'NIS Considerations' reports he created through CHCUK