FDA Proposal to Regulate Laboratory Tests

This comment is made in response to this announcement by the FDA in the Federal Register: Medical Devices: Laboratory Developed Tests

The author has been interested in the accuracy of  LDT’s (Laboratory Developed Tests) on both a professional and personal basis for decades. Based upon this experience it is recommended that priority be accorded to the regulation of urological oncology testing with an emphasis on Laboratory Developed Tests (LDT’s) developed by private laboratories. The initial program would  exclude   any immediate regulation of   the procedures developed by academic or hospital based entities  until the results of the regulation of private sector laboratories are complete and  a determination is made of the magnitude  of the resultant problem, if one exists.

The FDA proposal cannot become a binding regulation until which time it is  subjected to  the centralized regulatory review process. The author is the only individual who was involved in the formulation and initiation of centralized regulatory review over the course of five presidential administrations, from its inception (Johnson Administration) to its development (Nixon and Ford Administrations) to its codification (Carter Administration) and finally  to its  government-wide implementation (Reagan Administration). Centralized regulatory review consists of two major components, conducting benefit-cost analyses of proposed regulations  and  OMB review of proposed regulations, including their underlying benefit-cost analysis, as presented in the FDA proposal for public comment.  The website of the Center for Regulatory Effectiveness titled “Centralized Regulatory Review: An Archive” is devoted to  a detailed description of a comprehensive national library of the actions which lead to the historical establishment of centralized regulatory review within the Executive Office of the President of the United States over the past  half-century. All stakeholders should acquaint themselves with the fairness and objectivity of the processes inherent in centralized regulatory review as set forth in the aforementioned library and participate in its implementation.


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