FDA Regulation of Laboratory-Developed Diagnostic Tests: Protect the Public, Advance the Science

JAMA. 2015 Feb 17;313(7):667-8. doi: 10.1001/jama.2014.18135.

MeSH terms

  • Clinical Laboratory Techniques / standards*
  • Government Regulation*
  • Humans
  • United States
  • United States Food and Drug Administration*