PARSED CONTENT

The site had the following in the homepage, "The Common Sense approach to Regulatory Affairs." I noticed that the web site stated " Intended Use Vs Indications for Use." They also stated " The meanings of Intended Use and Indications for Use have very specific implications when fulfilling FDA requirements. FDA defines Intended Use as. A change to Intended Use warrants a new submission when it could significantly affect the safety or effectiveness of the device. FDA defines Indications for Use as. The key regulatory terms intended use and indications for use are poorly defined and are susceptible to vary."