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Old 23rd May 2007, 11:01 AM
chris1price

 
 
Total Posts: 211
Re: "Indication for Use" used in 510(k) - Indications for use vs. Intended use

Hi

In my experince, the Indications for Use are usually very specific and tend to be used in a regulatory framework, such as discussion with FDA on predicates or labelling. The indended use is more general and descriptive.

see

http://www.fda.gov/cdrh/devadvice/314312.html#link_6

***DEAD LINK REMOVED****

Last edited by Marc; 5th August 2010 at 12:58 PM. Reason: Dead link removed.
Thank You to chris1price for your informative Post and/or Attachment!

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