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Given the increasing pressure (17) for the FDA to extend the more rigorous regulatory mechanisms of 510(k) and premarket approval (PMA) registration to cover these LDTs (thereby significantly increasing the cost to laboratories offering them, and weeding out poorly validated and perhaps unapprovable analytes), it is in fact possible that the total number ofprotein tests offered clinically could decline substantially over the next few years.
We accept the disadvantages, namely that the same body will review protocols twice from slightly different perspectives and that certain categories of research will remain unapprovable.