R
RLDEARMOND
I work for a small component Medical Device manufacturer. At a recent conference our CEO was told by a consultent that because we machine bone screws that we have to have an FDA a facility license as bone screws are finished devices.
I diagree as we do not sterilize, package, label or market the screws. We only machine the screws and return them to the comapny that markets them.
I believe the consultant is just trying to get his foot in our door ($$$) but I would like a second opinion.
I diagree as we do not sterilize, package, label or market the screws. We only machine the screws and return them to the comapny that markets them.
I believe the consultant is just trying to get his foot in our door ($$$) but I would like a second opinion.