Thinking of getting involved in medical device ASICs or products? Need to be aware of the classification methods used by the FDA. Over the years the regulations seem to have changed.There is good news and there is bad news. In order to get the scoop from the “horses mouth” a good link is as shown below. The simplest classification from the point of view of the marketing of a medical device is Class I. Class II follows close behind with the 510(k) authorization to aim for. The hardest and the most complex classification is Class III. Need time and deep pockets for this type of device development and marketing! Most people will stay away from this. The following link should be helpful and is the place to start if thinking about entering the medical device market in the US.

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/default.htm