Introduction of a new medical procedure: a novel approach.

Before it is permitted for general use, a newly developed drug or medical device must undergo a series of pre-clinical testing and clinical trials to prove safety and efficacy. However, new medical procedures--even highly sophisticated and ethically controversial ones, such as organ transplants and I.V.F. do not require any clearance from regulatory authorities. This is an undesirable situation, which can be corrected by limiting legal liability for those who opt to perform new medical procedures as part of clinical trials. By this means we shall encourage a more prudent and better regulated introduction of new technologies into medical practice.