Impact of regulations on artificial organs research.
From a research perspective, some of the primary problems created by the FDA regulations include: the amount of time necessary to comply with the regulations and to obtain FDA and IRB review of the studies. The cost of such delays may be great in terms of statistical death. Lack of understanding of the regulations on the part of investigators. Escalated costs and extra restrictions on the use of animals. Benefits of the regulations appear to be: better preclinical testing performed prior to initiating clinical trials, and improved testing protocols, both of which may result in lower risks to patients.
D001187:Artificial Organs / Q000592:standards*; D006354:Heart, Artificial / Q000592:standards; D006801:Humans; D007878:Legislation as Topic; D014481:United States; D014486:United States Food and Drug Administration