FDA precertification program

HIMSSCast: FDA grapples with home COVID-19 testing, moves forward with Pre-Cert Program
By HIMSS Media | 05:31 pm | March 30, 2020
The HIMSS Media team gives a recap of recent headlines surrounding the FDA, COVID-19 and new digital health software products.
Q&A: A firsthand account of FDA's Pre-Cert Program
By Dave Muoio | 02:55 pm | March 27, 2020
Dr. Yuri Maricich, chief medical officer at Pear Therapeutics, speaks on his company's experience bringing a digital therapeutic product through the regulator's experimental program for health software.
FDA clears Pear's digital insomnia therapeutic through 510(k), Pre-Cert pilot pathways
By Dave Muoio | 04:53 pm | March 26, 2020
Somryst, a prescription digital therapeutic combining cognitive behavioral therapy and personalized sleep restriction, is the first software product to put the FDA's early Precertification Program framework through its paces. 
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. 
Pear Therapeutics' digital insomnia therapeutic will put FDA's PreCert framework through its paces
By Dave Muoio | 04:59 pm | July 22, 2019
CEO and President Dr. Corey McCann said that Somryst, a digital treatment for chronic insomnia and depression, is the first software as a medical device product to be submitted through the regulator's pilot pathway. 
FDA sought new PreCert participants, cleared new digital health products and more during Q2 2019
By MobiHealthNews | 04:19 pm | July 19, 2019
The agency also warned consumers of unregulated diabetes products and outlined plans for AI device regulation.
Roche, J&J regulatory leads weigh in on Pre-Cert's progress, challenges of regulating digital health
By Dave Muoio | 01:09 pm | June 04, 2019
At BIO 2019 in Philadelphia, a panel of industry experts discussed their experiences with the FDA's pilot program; ambiguities in drug, device and software pathways; and the hurdles digital health regulation has yet to properly address.
FDA regulations could create digital health opportunities for pharma
By Laura Lovett | 04:28 pm | March 28, 2019
A new report from PwC predicts that new and proposed FDA regulations could open up doors for pharmaceutical companies looking to develop digital tools.