When, if ever, does labeling for Prescription Medical Devices need to meet OTC regulations?
When, if ever, does labeling for Prescription Medical Devices need to meet OTC regulations?
Does labeling for a Prescription Medical Devices have to meet the regulations for OTC medical device labeling (21 C.F.R. 801.61, 21 C.F.R. 801.62, 21 C.F.R. 801.15)? If not, what are the minimum requirements for labeling content and presentation (placement, font size) for Rx only devices?
The provisions of Title 21 of the Code of Federal Regulations (C.F.R.) Part 801 set forth the requirements for medical device labeling. Prescription devices are not required to comply with the regulations for OTC devices, although the minimum type size requirements in 21 CFR 801.62 likely would be viewed as an appropriate guide for Rx devices as well.
FDA's guidance on the content needed for device labeling was developed many years ago but still appears to be in effect. This document, "Device Labeling Guidance (G91-1)," is available by clicking here. In general, FDA appears to be relatively flexible when it comes to the format and presentation of medical device label information.