PreCert

Fragmentation, regulations pose unique challenges for Europe's digital health market
By Laura Lovett | 01:51 pm | December 06, 2019
This week at the EIT Health Summit in Paris entrepreneurs, industry players, regulators and investors came together to discuss the opportunities for health innovation in Europe, and its relationship to the US market. 
Applying data science principles to FDA’s PreCert Program: Some scary stuff
By Bradley Merrill Thompson | 03:08 pm | November 01, 2019
Epstein Becker & Green's Bradley Merrill Thompson explains why the FDA PreCert Program's built-in subjectivity and bias toward established entities should worry the healthcare and medical technology industry.
Trio of US senators continue to question FDA's PreCert efforts
By Laura Lovett | 01:54 pm | October 30, 2019
Senators Elizabeth Warren, Patty Murray and Tina Smith continued to express concerns about the PreCert's 'Excellence Appraisals,' De Novo pathway and real-wrold performance markers.  
FDA releases midyear update on PreCert's Test Plan
By Laura Lovett | 03:23 pm | July 23, 2019
The organization reports it has completed retrospective testing and is in the process of prospective testing.