Sunday, April 9, 2017

ACLA Generally Supportive of Statutory FDA Reform for CLIA Labs and IVDs

On March 21, Dr. Larry Bucshon (R-IN) and Diana DeGette (D-CO) released a discussion draft of the Diagnostic Accuracy and Innovation Act (DAIA), along with summary documents.  In general, this is built on the Diagnostic Test Working Group (DTWG) approach circulated in the previous session of Congress.  ACLA has come out as generally supportive.  Details follow.

Hill Lab Proposal Released in Late March

An initial press release for the legislation is here, with a 2-page summary here, a 5-page summary here. and the whole 215-page statutory proposal here.

ACLA Generally Supportive in Early April

On April 7, ACLA issued a generally favorable press release in support, here, also releasing ACLA's detailed letter to the Hill, here (should open in window) or here (should open in Google docs) or here.

Get all six documents in one cloud zip file here.

In March, ADVAMED initially released a rapid, generally favorable short press release, here.  Similarly, Labcorp, here.  For an initial summary at RAPS, here, and for early coverage at Genomeweb, here.