Decision Diagnostics Corp (DECN)

[Mr Sensitivity]

Intended Use never changes on any medical product after it is cleared. The Intended Use statement is part of a 510(k) application. What does change is what is called Modifications Guidelines, where a company is able to modify the product labeling if they determine something new or different about the product that does not involve a product reformulation. Such as:

"This product was not tested on pediatric patients but scientific studies completed by two unrelated third parties in 201_....."