question about FDA clearance for products already being sold
Hello guys,
I am trying to figure out that if there is any clearance still required from FDA if I start selling any class-1dental or diagnostic devices which are already sold by my sellers in market. If I launch the same devices in market with my brand on it, will they still require me to file a PMA?
Since the devices are same as already sold but they are going to be private label to me.
I consulted FDA knowledgebase but i couldn’t find the specific answer.
submitted by /u/SnooMacaroons1365
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