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.

FDA Guide to Bioresearch Monitoring Inspections of in vitro Diagnostic Devices

Origin/Publisher:

FDA

Content:
The purpose of this guide is do describe that bioresearch monitoring inspections is to ensure that data and information contained in premarket applications are scientifically valid and accurate.

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