The U.S. Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) regulates medical devices, including software-as-a-medical-device (SaMD).
regulators. The U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) regulates medical devices, including software-as-a-medical-device (SaMD)..
As regulatory processes and reimbursements are refined, there needs to be a continued focus on how to maximize the benefits for patients and ensure DTx can play a role in improving outcomes. The key to this is integration into the clinical workflow.
Consumer demand for health and wellness products has seen vast growth in recent years. The COVID-19 pandemic and its aftermath has also resulted in broader avenues through which consumers.
In Short - The Situation: With the calendar officially turned to a new year several significant changes and regulatory initiatives are on the horizon at the Food and.