What is the FDA's role in the approval of point-of-care PT/INR devices for monitoring warfarin therapy?
The U.S. Food and Drug Administration (FDA) evaluates and approves point-of-care PT/INR devices before they can be used in clinical settings. The FDA requires that the device be accurate, reliable, and safe for patients to use. Additionally, the FDA considers the device's usability, accuracy, and performance in real-world settings before approving it for use. The FDA also provides guidance documents for manufacturers to ensure they are meeting the necessary regulatory requirements.  