Hello,
Does an entity (i.e. cannot sell devices by law) which only provides medical devices for Clinical Trial under an IDE fall under the definition of Manufacturer per 21 CFR 820?
It is not clear to me as the definition for finished allows some wiggle room there.
"Finished device means any device or accessory to any device that is suitable for use or capable of functioning, whether or not it is packaged, labeled, or sterilized."
Thank you
Does an entity (i.e. cannot sell devices by law) which only provides medical devices for Clinical Trial under an IDE fall under the definition of Manufacturer per 21 CFR 820?
It is not clear to me as the definition for finished allows some wiggle room there.
"Finished device means any device or accessory to any device that is suitable for use or capable of functioning, whether or not it is packaged, labeled, or sterilized."
Thank you