A Historical Perspective on Regulation of In Vitro Diagnostics

Posted 01 May 2011 | By Robert Schiff, PhD, RAC, CQA, FRAPS 

In vitro diagnostics, commonly referred to as IVDs, have been regulated for many years by the US Food And Drug Administration (FDA), its precursors and related government bodies. Prior to the establishment of the Medical Device Amendments of 1976, there were few federal requirements for manufacturing and sale of IVDs although some did exist and will not be discussed here.

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