Top-Quality Clinical Studies For Medical Devices, FDA Seeks Feedback On Proposed Guidelines
In order to optimize the standard of clinical studies that support the PMA (premarket approval) submissions for medical devices, the FDA has issued a draft guidance. The FDA (Food and Drug Administration) says its draft guidance aims to help manufacturers and researchers design better quality clinical studies. The Agency is also calling on experts, manufacturers, researchers, and other groups to ...

FDA Issues New Guidance for 510(K) Medical Device Approvals
The U.S. Food and Drug Administration (FDA) just issued new draft guidance for 510(K) device approvals. The draft guidance clarifies when changes or modifications to a previously cleared 510(k) device require a new premarket submission. Congress gave the FDA authority over medical devices in 1976 and allowed it a quick review process for new devices it [...]

New report urges overhaul of medical device approvals
The Institute of Medicine says the FDA's current approach doesn't meet its goals.