Question

Almost any new medical technology for consideration by an investor will insist on safety and efficacy approval by a government regulator like the United States FDA. Furthermore they will insist on an assessment of whether the intellectual property (IP) that the innovation operates in is not conflicting with other IP claims. For this milestone you will complete a brief assessment of how the innovation would be classified by the US FDA as well as generate a very cursory patent search for conflicting IP claims using common and free tools on the Internet such as Google patent search and the US Patent and Trademark office web site.

Answer 1

The FDA catagorizes the innovation into one of the three classes - Class I, class II and class III based on their risks and the regulatory controls necessary to provide a reasonable assurance of safety and effectiveness.

Class I - are those that have a low to moderate risk to the patient and or user. If a device falls into a generic catogory of exempted class I devices, a premarket notification application and FDA clearance is not required before markett them in the U. S.

Class II- are those that have a moderate to high risk to the patient and or user.

Class III- are those that have a high risk to the user