June 8, 2011 – The U.S. Food and Drug Administration (FDA) has released its list of pre-market approval (PMA) and 510(k) decisions for new or enhanced medical devices from March 2011. The list includes all FDA PMAs , product development protocols (PDP), supplement and notice decisions. This list is generated on a monthly basis.
PMAs are granted for new devices and 510(k) approvals are granted for device’s cleared commercialization that are substantially similar to a previously FDA cleared device.
The list of new PMAs can be accessed at www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/PMAApprovals/ucm258003.htm
The list of new 510(k) decisions can be accessed at: www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/510kClearances/ucm258481.htm