Bradley Merrill Thompson

Motor vehicles stalled in a traffic jam
By  Bradley Merrill Thompson 09:35 am December 23, 2020
It’s been quite a year: COVID-19, a change in administration and a year of transition for FDA digital health policy. In light of all the change and uncertainty, many digital health companies are struggling to decide upon a regulatory strategy for 2021. My advice? If at all possible, stay away from FDA. They have enough to do right now. The people I know at FDA have been working 12- and 15-hour...
By  Bradley Merrill Thompson 02:08 pm November 1, 2019
About the Author: Bradley Merrill Thompson is a member of the firm at Epstein Becker & Green, P.C. There, he counsels medical device, drug, and combination product companies on a wide range of FDA regulatory, reimbursement and clinical trial issues. The opinions in this piece are Thompson's and don't necessarily reflect the opinions of MobiHealthNews or HIMSS. Let’s say I could show you,...
By  Dave Muoio 12:09 pm June 4, 2019
Since it was first announced, fans and critics of the FDA’s Pre-Cert program for medical software developers have mused on the benefits and burdens that might come with participation in the experimental program. What to expect from Pre-Cert The question has only become more pertinent since the agency released its 1.0 Working Model in January and, just a couple weeks ago, began seeking new De Novo...
Some false or misleading guidances on FDA's website.
By  Bradley Merrill Thompson 11:07 am March 8, 2019
About the Author: Bradley Merrill Thompson is a member of the firm at Epstein Becker & Green, P.C. There, he counsels medical device, drug, and combination product companies on a wide range of FDA regulatory, reimbursement, and clinical trial issues. The opinions in this piece are Thompson's and don't necessarily reflect the opinions of MobiHealthNews or HIMSS. As a pro bono project, together...
A generic startup

Photo by Caiaimage/Chris Ryan

By  Bradley Merrill Thompson 11:44 am February 8, 2019
About the Author: Bradley Merrill Thompson is a member of the firm at Epstein Becker & Green, P.C. There, he counsels medical device, drug, and combination product companies on a wide range of FDA regulatory, reimbursement, and clinical trial issues.  In January, FDA released version 1.0 of its Working Model for the agency’s Precertification Program for Software as a Medical Device (SaMD) (i....

  (Photo by Drew Angerer/Getty Images)

By  Laura Lovett 10:25 am January 8, 2019
The FDA unveiled new updates on the ongoing Pre-Cert program including a Digital Health Innovation Action Plan, Pre-Cert Test Plan for 2019 and a Working Model.  One of the big take aways from yesterday's announcement is that the FDA is looking to use the De Novo model to implement the next phase of the Pre-Cert pilot. The second is that the organization plans on setting up a parallel submission...
By  Bradley Merrill Thompson 11:20 am September 7, 2018
About the Author: Bradley Merrill Thompson is a member of the firm at Epstein Becker & Green, P.C. There, he counsels medical device, drug, and combination product companies on a wide range of FDA regulatory, reimbursement, and clinical trial issues. The opinions in this piece are Thompson's and don't necessarily reflect the opinions of MobiHealthNews or HIMSS. FDA’s concept of a...
By  Jonah Comstock 04:43 pm April 26, 2018
This morning, the FDA published its 17-page first draft of a working model for its pre-certification program for software as a medical device (SaMD). Though still preliminary (the agency is asking for comments by the end of May), the publication comes with some long-awaited details about how the program might work. The document lays out five "excellence principles" on which companies applying for...
By  Jonah Comstock 04:34 pm December 7, 2017
FDA Commissioner Scott Gottlieb dropped three new FDA guidance documents today, two draft guidances and a final guidance. One draft guidance is the long-awaited guidance on clinical (as well as patient) decision support, while the other deals with changes to medical software policy based on Congressional mandates in the 21st Century Cures Act. The final guidance is on Software as a Medical Device...
By  Bradley Merrill Thompson and Chris Bergstrom 09:22 am October 27, 2017
About the Authors: Bradley Merrill Thompson is a member of the firm at Epstein Becker & Green, P.C. There, he counsels medical device, drug, and combination product companies on a wide range of FDA regulatory issues.  Chris Bergstrom is a digital health leader, for The Boston Consulting Group (BCG). At BCG, he directs digital health initiatives across large payer, provider, med tech, and bio/...