Medical device manufacturers are required through FDA 21 CFR Part 803 to submit Medical Device Reports when their devices are involved in patient safety issues or product malfunctions. The FDA receives over 300,000 Medical Device reports (or MedWatch reports) annually, of which all were once entered manually into their Adverse Event databases. Not any more. The FDA has tested and opened for business its electronic gateway for filing electronic Medical Device Reports (eMDR). Click here to read more.

Ein Sonderdruck aus der DeviceMed Ausgabe Mai 2008