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A Nov. 22 article in D&DL questioned whether the FDA’s plan to create a new database to replace the Manufacturer and User Facility Device Experience (MAUDE) would delay the mandatory implementation of electronic medical device reports (eMDRs) (D&DL, Nov. 22). The agency clarified last week that the replacement for MAUDE is separate from the eMDR system, and a final eMDR rule is still on tap for mid-2011. Furthermore, disruptions in eMDR filing are only in the test system, the FDA reiterated.