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.

Alternative to Certain Prescription Device Labeling Requirements
Internet:	http://www.fda.gov/cdrh/comp/rxlabeling.pdf
Origin/Publisher:	FDA http://www.fda.gov/cdrh/comp/rxlabeling.pdf
Content:	The guidance for industry addressess manufacturers, repackers, relabelers, and distributors of prescription devices which may wish to use the same symbol statement “Rx only” as an alternative to the prescription labeling requirements, under sec.801.109.
Status:	Guidance for Industry
Document Type:	Guidance for Industry