California Food & Drug Branch require components manufacturer to obtain license?

#1
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.
 
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#3
Compare this statement to the US FDA's definition of "medical device" at http://www.fda.gov/MedicalDevices/D...nce/Overview/ClassifyYourDevice/ucm051512.htm. The differences are minor...I think the California wording was based on the Federal wording.

"Component" as used in the Federal definition has substantially the same meaning as "accessory" in the same definition. "Accessory" in the MDD definition of a device is used similarly.

The key is the intended-use requirement. A bolt, a capacitor or a general purpose video monitor has lots of potential uses...there's nothing about it that makes it specifically intended for use in a way that fits into the second or third clauses of the Federal definition, or into the similar California one. The definition is intended to capture accessories and components that are specifically designed for use with a device, and have no non-medical-device intended use.

So, if the product you make has significant non-medical uses and isn't marketed specifically for a medical intended use, you're excused.
 
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