How to decide if an IND / IDE may be needed?
FDA considers the entire combination product in determining the need for an investigational application. For example, in some investigational protocols one part of the combination product might be already approved but another part is new and raises safety risks. Therefore, the entire combination product raises a safety risk and would be under an investigational application. In some instances both the drug and device are already approved for different indications, but when the two are used together a new risk exists. In such cases, the combination product as a whole would be under an investigational application. [The following links may provide preliminary information on the IDE process for devices alone http://www.fda.gov/oc/ohrt/irbs/devices.html and for drugs http://www.fda.gov/cder/about/smallbiz/faq.htm#submit%20an%20IND?
