Hi,
First, I'm so appreciative of this forum. Now my question: I've been told that the California Food and Drug Branch (CA FDB) requires that a manufacturer -A-(residing in California) of components that go in another manufacturer's -B- finished medical device must apply for a medical device license. This is according to the Sherman Food Drug and Cosmetics Act (see sections quoted below). I called the CA FDB to ask, and they confirmed it, about the manufacturer of components that go into another's finished device having to be licensed. To me, that seems unreasonable. I can see that finished device contract manufacturers need to apply for a license, but components? Please advise if this is true if you've dealt with CA FDB.
111615. No person shall manufacture any drug or device in this state unless he or she has a valid license from the department...
109920. ?Device? means any instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, that is any of the following:...
(b) Intended for use in the diagnosis of disease or other condition, or in the cure, mitigation, treatment, or prevention of disease in humans or any other animal.
109970. ?Manufacture? means the preparation, compounding, propagation, processing, or fabrication of any food, drug, device, or cosmetic. The term ?manufacture? includes repackaging or otherwise changing the container, wrapper, or labeling of any food, drug, device, or cosmetic in furtherance of the distribution of the food, drug, device, or cosmetic. The term ?manufacture? does not include repackaging from a bulk container by a retailer at the time of sale to its ultimate consumer
Thank you.
First, I'm so appreciative of this forum. Now my question: I've been told that the California Food and Drug Branch (CA FDB) requires that a manufacturer -A-(residing in California) of components that go in another manufacturer's -B- finished medical device must apply for a medical device license. This is according to the Sherman Food Drug and Cosmetics Act (see sections quoted below). I called the CA FDB to ask, and they confirmed it, about the manufacturer of components that go into another's finished device having to be licensed. To me, that seems unreasonable. I can see that finished device contract manufacturers need to apply for a license, but components? Please advise if this is true if you've dealt with CA FDB.
111615. No person shall manufacture any drug or device in this state unless he or she has a valid license from the department...
109920. ?Device? means any instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, that is any of the following:...
(b) Intended for use in the diagnosis of disease or other condition, or in the cure, mitigation, treatment, or prevention of disease in humans or any other animal.
109970. ?Manufacture? means the preparation, compounding, propagation, processing, or fabrication of any food, drug, device, or cosmetic. The term ?manufacture? includes repackaging or otherwise changing the container, wrapper, or labeling of any food, drug, device, or cosmetic in furtherance of the distribution of the food, drug, device, or cosmetic. The term ?manufacture? does not include repackaging from a bulk container by a retailer at the time of sale to its ultimate consumer
Thank you.