Does a US FDA Class I (exempt) device require a Statement of Intended Use?

B

Bunny

Does a US FDA Class I (exempt) device require a statement of intended use?
 
M

MIREGMGR

Re: Statement of intended use

Does a US FDA Class I (exempt) device require a statement of intended use?

Yes. Every US FDA regulated medical device must be associated with a clear communication to end users of the intended use(s). See 21CFR 801.4 and 5, and guidance memo G91-1.
 

RA Guy

Involved In Discussions
Re: Statement of intended use

Aside from the formal requirement cited by MIREGMGR for labeling purposes, one could argue that the inteded use is needed early in the development process to determine if the products meets the definition of medical device and if so what class it assumes.
 
M

MIREGMGR

I don't know about the OP's instance, but an historically common reason not to state an intended use is so as to facilitate marketing of a device for a use that is not consistent with its classification, its premarket approval, or legal device boundaries.

FDA specifically addresses such circumstances. FDA will assume that any communication to potential users by (more or less) anyone that in any way encourages or supports a use is marketing and a declaration that that use is an intended use, and will regulate on that basis.

De facto marketing of products for uses outside of their proper intended use, if any, is (I think) historically the second most common reason for Warning Letters, after lack of proper complaint handling procedures.
 
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