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.

In Vitro Diagnostic Devices: Guidance for the Preparation of 510(k) Submissions
Internet:	http://www.fda.gov/cdrh/manual/ivdmanul.html
Origin/Publisher:	FDA http://www.fda.gov/cdrh/manual/ivdmanul.html
Content:	This manual covers premarket notification requirements for medical devices. It contains guidance of significance to manufacturers and importers of medical devices.
Status:	Guidance
Document Type:	Guidance