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21 CFR 807.81 When a premarket notification submission is required

PacoRabanez

Starting to get Involved
#1
Hi all.
I recently asked for the real meaning of "commercial distribution" cited in the 21 CFR 807.81, when a premarket notification (510(k)) is required.

I contacted FDA and they clarified the following:
In order to be considered commercialized, you don't actually have to sell the the device, you simply have to make any results produced from its use available to others.

Hope it'll be useful for others.

Greetings.
 
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