US FDA Medical Device Label Requirements

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Arnthor

Dear all,

i have a situation that need some help.

My firm is located in country A and we got a sister plant in country B.

In the past, my sister plant in country B will ship the finished medical device back to country A for sterilization, inspection and export to US. On our packaging label we indicated that we are the manufacturer of this medical device.

Now my firm is going to ship the sterilization process to my sister plant in country B and my firm in country A is going to become non-manufacturing firm.

According to 21 CFR 820 definition of manufacturer,
"Manufacturer means any person who designs, manufactures, fabricates, assembles, or processes a finished device. Manufacturer includes but is not limited to those who perform the functions of contract sterilization, installation, relabeling, remanufacturing, repacking, or specification development, and initial distributors of foreign entities performing these functions."

My firm is responsible for the design and specification developement for the medical device, so does that made us a manufacturer?

If yes? Can my firm still quoted that we are the manufacturer on the packaging label? Or i have to change the manufacturer to my sister plant in country B?

Or can I put my firm name in country A and add a statement: "Made in country B"?

Please advice.

Arnthor
 
M

MIREGMGR

There are multiple questions here.

First, regarding FDA Manufacturer determination: it's a company, not a plant, that's a (potential) Manufacturer. Are your plants in countries A and B part of the same (legal) company, or are they related but separate companies?

In any case, you can structure this whichever way you want. Presumably at some point in the past you registered the company associated with the plant in country A as a Manufacturer, and that company Listed the product. You could continue with that scenario, except with the A-plant's registration basis changed to Specification Developer. In that scenario, the B-plant is a contract manufacturer/sterilizer, and need not be registered. Or, you could newly register the B-plant as a Manufacturer, have it list the device, and discontinue the A-plant's registration and listing.

If the two plants are part of the same company, some of the shuffling in the second scenario could be avoided by means of an address change at the DLRM registration-and-listing site.

Second, regarding a Made In statement on the label of a device to be imported into USA: that specific statement is governed by the US Department of Commerce rules (i.e. the Customs and Border Protection Service), not the FDA labeling requirements. Thus a device may be Manufactured, for FDA registration purposes, in a different country than where the label says it's Made. Per US CBPS rules, the Made In statement must refer to the last country where a substantial transformation occurs. In your intended-change manufacturing plan, it sounds to me as if the Made In statement must identify Country B.
 
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