FDA updates eMDR
Device Regulation Alert: Safety, Compliance and Reimbursement News, January 14, 2008
In December, the FDA provided an update on its Web site concerning electronic medical device reporting (eMDR), which calls for electronic submission and processing of medical device adverse event reports. The update discusses the standards used to submit reports and two options for entities making reports.
The first option is a free downloadable application used to submit one report at a time. The second option allows submission of electronic medical device reports either individually or in groups. The update also provides links to additional information about both options and about the FDA Gateway that allows FDA to receive reports.
Click here to view the update and to sign up for future e-mail updates about eMDR.
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