Bradley Merrill Thompson

By Dave Muoio 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 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 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 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 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 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 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...
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/...
By MHN Staff September 10, 2015
by Bradley Merrill Thompson Let’s say no one had ever invented the tongue depressor, but this year, in a flash of inspiration, I came up with the idea. Indeed, let’s say there’s nothing else like it. To bring the first tongue depressor to market, it’s quite likely I would have to spend years conducting clinical trials, to be followed up by perhaps a year of FDA review. For a tongue depressor. Why...
By MHN Staff August 5, 2015
By Bradley Merrill Thompson Healthcare in America needs disrupting. The media has widely reported on the high cost of, and poor outcomes produced by, the US health care system. Fortunately, attracted by possible profit in a market that currently constitutes over 17 percent of GDP, quite a few startups are anxious to do the needed disrupting. Indeed, innovators from many places outside of...