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Guideline

The following guideline can be ordered through the address listed in the "Source/Publisher"-category.
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Third Party Review; An Instruction Manual For Conducting Reviews of Premarket Notifications
Internet:http://www.fda.gov/cdrh/thirdparty/apguide13.pdf
Origin/Publisher:FDA http://www.fda.gov/cdrh/thirdparty/apguide13.pdf
Content:This guidance is for those who are interested in the Food and Drug Administration’s (FDA’s) third party review program.
Status:Guidance
Document Type:Guidance