Industry concerns with the regulatory process

Summary form only given, as follows. The Food and Drug Administration has a significant responsibility to protect the public health by regulating the clinical investigation and marketing approval of new medical device technologies. The medical device industry is also concerned with protecting and improving the public health by marketing new technologies available. It sometimes appears to industry that the FDA's demands for extensive in vitro, animal, and clinical data delay the introduction of new devices that will benefit the public. The author believes that the FDA's requirements are sometimes more extensive than appropriate, because the FDA is more concerned with patient safety than with the potential benefits of the new device, instead of balancing the benefits and risks. To improve the situation, engineering and scientific organizations must (a) educate the public about reasonable expectations of safety and effectiveness for new devices and (b) work with FDA to develop test protocols to provide the appropriate data.