Down Classifying a Medical Device from Class II to Class I

DCONN1

Starting to get Involved
#21
Thank you everyone very much for the replies and interesting discussion.

In response to Marcelo's question:

Why would you need a recall of device which were marketed in compliance with the regulations they should comply?
It seems to me that a market withdrawal/recall for the Class II devices would be appropriate at least for practical reasons if the name of the product remained unchanged. Otherwise, the product would be on the market with two different forms of labeling in terms of the indications for use in the IFU. Technically from a regulatory standpoint they would be two separate products (and would be listed as such on the FURLS device listing, but with the same product name). I'm thinking in more practical concerns for avoiding confusion, but does anyone see any concerns from a regulatory standpoint with not withdrawing the Class II-labeled products from market?
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
#22
It seems to me that a market withdrawal/recall for the Class II devices would be appropriate at least for practical reasons if the name of the product remained unchanged. Otherwise, the product would be on the market with two different forms of labeling in terms of the indications for use in the IFU. Technically from a regulatory standpoint they would be two separate products (and would be listed as such on the FURLS device listing, but with the same product name). I'm thinking in more practical concerns for avoiding confusion, but does anyone see any concerns from a regulatory standpoint with not withdrawing the Class II-labeled products from market?
I would see a problem with stock, but if you sold all the devices under Class II, and then you begin sell all of them as Class I, I would not think it's a big problem. Surely this might cause a small confusion, in particular for people who bought the Class II one, but I don't think an extreme measure such as a recall would be needed. Anyway, you should probably discuss this with the FDA, for example.
 

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