FDA Alternative to Certain Prescription Device Labeling Requirements
Title:
FDA Alternative to Certain Prescription Device Labeling Requirements
Origin/Publisher:
FDA
Document Type:
Guidance for Industry
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.