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.

Premarket Approval Manual
Internet:	http://www.fda.gov/cdrh/manual/pmamanul.pdf
Origin/Publisher:	FDA http://www.fda.gov/cdrh/manual/pmamanul.pdf
Content:	This manual details the type of information needed in a PMA so that the Food and Drug Administration (FDA) can evaluate the safety and effectiveness of a medical device.
Status:	Withdrawn
Document Type:	Manual