FDA chooses new system for medical-device reports

09/25/2013 | Regulatory Focus · FDAnews

The FDA's Manufacturer and User Facility Device Experience system will be replaced by Pharmacovigilance Report Intake and Managed Output software from November Research Group. MAUDE is so old that an FDA official has joked that it's a good fit for a museum. The Center for Devices and Radiological Health could see the PRIMO software rolled out this year.

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Regulatory Focus · FDAnews

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