Transdermal patches
Transdermal patches are considered as devices (by US FDA)
I am looking for templates/formats used in typical regulated environment, and for combination products, devices or drug+device combinations.
any references would be of great help.
Transdermal patches are considered as devices (by US FDA)
(b) Device with primary purpose of delivering or aiding in the delivery of a drug and distributed containing a drug (i.e., "pre*filled delivery system")
EXAMPLES
EXAMPLES
- nebulizer
- oxygen tank for therapy and OTC emergency use
- pre*filled syringe
- transdermal patch
any references would be of great help.
