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Guideline

The following guideline can be ordered through the address listed in the "Source/Publisher"-category.
In cases in which you can order through the Internet we have established a hyperlink.

Medical Device Reporting for Manufacturers
Internet:http://www.fda.gov/cdrh/manual/mdrman.pdf
Origin/Publisher:FDA http://www.fda.gov/cdrh/manual/mdrman.pdf
Content:This guidance document describes the new Medical Device Reporting requirements for manufacturers.
Status:Guidance
Document Type:Guidance