Thursday, August 16, 2018

FDALawBlog posts FDA's 59-page Diagnostics Legislation for Reform of Itself


Takeaway:
Attorney Jeff Gibbs of Hyman Phelps has posted an article at FDA Law Blog where he both discusses the FDA documents in more detail, and posts a public link to them.  
  • Blog here.  
  • FDA two-pager here
  • FDA 59 page legislative document here.
click to enlarge
In addition to Gibbs' blog, see an August 21, 2018, long article at MedTechDive, here.

Brief Background
The lab community has been talking about different versions of the Diagnostics Accuracy and Innovation Act (DAIA) for several years.  A high point was the release of a long Hill draft bill in 2017, which elicited numerous rounds of comments, both at the time and recently.  (Just google the terms DAIA and diagnostics, here).

On August 14, 2018, at FDA Law Blog, attorney Jeff Gibbs both discusses the FDA's legislative document(s) and provides the reader with links to the documents.   Initial trade press did not hotlink the actual FDA documents.

My earlier August 9 blog on the topic still here.

Clip from Jeff Gibbs' August 14 Blog:
     
     ....FDA’s TA document is not tinkering with the regulatory regime for IVDs. It is a revamp of how all IVDs should be regulated, LDTs and distributed diagnostic products alike.     ....FDA was asked to provide Technical Assistance (TA) regarding legislation, the Diagnostic Accuracy and Innovation Act (DAIA), that is designed to accomplish these and other goals.
     In response, FDA went much further than providing technical comments on the legislation.  FDA has instead advanced a different framework, with different statutory language, which would substantially change the regulatory regime for in vitro diagnostics (IVDs).   As FDA said in accompanying comments, the agency is “taking a fresh look at how the Agency is encouraging the development of innovative tests and continuous improvements to diagnostics already on the market.”  Underscoring that the TA is not just tweaking existing mechanisms, FDA says it “believes it is necessary to create pathways” (emphasis added).
While promising an even more detailed review to come, Gibbs notes:  "Rewriting the laws for IVDs is a complicated business, and every word needs to be scrutinized, both for what is intended and for potential unintended consequences.  There are multiple pieces to the new jigsaw puzzle FDA has proposed."