The U.S. Food and Drug Administration has proposed banning powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon’s glove. Powdered radiographic protection gloves would not be included in the ban.
What are the Requirements for Medical Device Packaging?
Is a special DMF required for packaging materials used to package medical devices or will a DMF set for packaging materials used for food and...
Is There Ever a Time When a Class I or II Device Need not Comply with OTC Regulations on Labeling?
Does the label on the primary and secondary pack of a Class I or II device need to comply with the OTC regulation when the device is always...
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...