Clinical Trial Requirements for Cardiac Devices

Currently, in the United States, the required time to develop a new cardiac device and gain approval for market release is highly dependent on the time it takes to perform proper clinical trials. For such, both safety and efficacy data are generated for the purpose of receiving clearance or approval from the United States Food and Drug Administration (FDA). The clinical trial processes for early cardiac medical device concepts are especially stringent with numerous requirements and regulations that must be complied with. Early medical device concepts that show promising safety and/or efficacy results in preclinical trials, bench top testing (including accelerated wear testing), a virtual prototyping environment, and/or computation modeling studies may apply for an investigational device exemption (IDE); allowing for implantation in human subjects via clinical trials to support the FDA premarket approval (PMA) process for Class III devices (and less commonly, a 510(k) submission for Class II devices).