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We would like to put both our indications for use and intended use in our user manual.
Is this safe to say:
- Intended use: is the same statement as what we submit in the 510(k) in the "indications for use" page that is made public
- Indications for use: is the more detailed version of the intended use (above). It could be made up, or summarize, the other portions of the 510(k), going into even more detail as to the contraindications, disease states, patient populations, etc.
Or, is the intended use a very general statement, and could even be derived from a GMDN code, or product code, and the "Indications for use" statement is the copy/paste of the indications for use page in the 510(k)?
Please help!
-Elaine
Is this safe to say:
- Intended use: is the same statement as what we submit in the 510(k) in the "indications for use" page that is made public
- Indications for use: is the more detailed version of the intended use (above). It could be made up, or summarize, the other portions of the 510(k), going into even more detail as to the contraindications, disease states, patient populations, etc.
Or, is the intended use a very general statement, and could even be derived from a GMDN code, or product code, and the "Indications for use" statement is the copy/paste of the indications for use page in the 510(k)?
Please help!
-Elaine