• MORE ARTICLES

• Knowledgebase

• Interpret FDA's QSR

• Find Regulatory Requirements for your country
• GHTF
• Validation Requirements
• Medical Device Software
• Sterilization

• FDA Requirements
• European Union Requirements
• Canadian Requirements

FDA’s “Intended Use” and “Indications for Use”

For a more detailed analysis of the specificity to which one should set their Indications for Use statement see the FDA guidance document:

Guidance for Industry: General/Specific Intended Use

In conclusion, the Indications for Use statement, as defined by the FDA, has very precise structure.  The Intended Use on the other hand is a regulatory term that describes an overall picture.  You are still responsible for defining Intended Use and ensuring that your product is used as such.  In the end your submission package will be spearheaded by your Indications for Use statement.    You will be held accountable for what you put in it as well as what you leave out.

End of article

Go to start of article