Thursday, January 8, 2015

ACLA Releases New Position Paper against FDA LDT Regulation; AMA Weighs in Too

On January 7, the American Clinical Laboratory Association (ACLA) released a detailed legal white paper on why the FDA does not have the authority to regulate laboratory developed tests.   The press release is here, the legal white paper here.  

ACLA released, on the web here,  its oral comments at the January 8-9,2015 FDA public workshop on LDT regulation.

Last summer, the FDA responded to three Citizen's Petitions for and against FDA LDT regulation, with the petitions and the FDA's responses to each clipped below. 

'06, '08, '13 Petition
7/2014 FDA Response

The subscription website Genomeweb interviews the ACLA legal authors, here, and a counterpoint, here.

  • Also this week, the AMA publicly released its letter to the House "21st Century Cures" group, which requested public feedback on the FDA LDT issue by this week.  
  • AMA document, here.