Is FDA Establishment Registration for Bulk packaging Contract Manufacturers ?


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One of our location in US manufactures an accessory that is bulk packed and sends to the customer. The customer in turn packages individually in the saleable pack, labels and does commercial distribution.

The customer wants us to have a Device Listing for the above mentioned product but our stand has been that we are sending "Components" to them (since its bulk pack) and they manufacture a finished devices since final packing and labeling is another step in manufacturing.

But the customer feels that since we already mold a finished accessory, we must have FDA establishment and get the device listed. Is our stand on the interpretation of the "component" is correct ?


For US FDA regulatory purposes, any "finished medical device" is fully subject to regulation and must be manufactured by a Registered Establishment. 21 CFR 820.3(l) defines a "finished medical device" as "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."

This definition has been held by FDA many times to define as a "finished device" at time of first sale a product that would perform a medical function in the hands of a clinical end user, even though it is sold by its maker only in bulk form and only to kit packers or repackager/relabelers.

A "component", as referred to in 21 CFR 807.65(a), is a fabricated article that does not meet the definition of a finished medical device.

Is our stand on the interpretation of the "component" is correct ?

No. You are a device maker, not a component maker. Your customer is either a kit packer or a repackager/relabeler, not a device maker.
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