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. 
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. 
Poll results: Readers support FDA Pre-Cert
By Jonah Comstock | 11:32 am | September 17, 2018
The results to our poll about the FDA program prompt questions about the program's fairness to companies big and small.
Commentary: Why FDA’s software precertification program may be bad for business
By Bradley Merrill Thompson | 12:20 pm | September 07, 2018
Epstein Becker & Green's Bradley Merrill Thompson says the FDA's much-touted program is riddled with unseen costs and unanswered questions.