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


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Related Topic Tags
class i exempt medical device, fda (food and drug administration), intended use (medical devices), medical devices (general), statement of intended use, 21 cfr part 801 - labeling
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  Post Number #1  
Old 13th April 2012, 08:03 AM
Bunny

 
 
Total Posts: 244
Question Does a US FDA Class I (exempt) device require a Statement of Intended Use?

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

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  Post Number #2  
Old 13th April 2012, 11:21 AM
MIREGMGR

 
 
Total Posts: 3,685
Re: Statement of intended use

Quote:
In Reply to Parent Post by Bunny View Post

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.
Thanks to MIREGMGR for your informative Post and/or Attachment!
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  Post Number #3  
Old 13th April 2012, 03:38 PM
RA Guy

 
 
Total Posts: 57
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.
Thanks to RA Guy for your informative Post and/or Attachment!
  Post Number #4  
Old 13th April 2012, 03:50 PM
MIREGMGR

 
 
Total Posts: 3,685
Re: Does a US FDA Class I (exempt) device require a Statement of Intended Use?

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.
Thanks to MIREGMGR for your informative Post and/or Attachment!
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