Publications

May 6, 2015 – Article
Working Out the Bugs: Congress Wants to Clarify FDA Software Regulation
MDDI
Bradley Merrill Thompson

April 2015 – Article
FDA Releases from Regulation Certain Digital Health Solutions Aimed at Chronic Disease
The Journal of mHealth
Bradley Merrill Thompson

April 13, 2015 – Article
FDA Medical App Regulation and the Art of Intended Use
MobiHealthNews
Bradley Merrill Thompson

March 24, 2015 – Article
Help Low-Income Neighbors Fight Legal Injustice
Current in Zionsville
Bradley Merrill Thompson

March 14, 2015 – Article
Regulatory Framework for Clinical Decision Support Software: Present Uncertainty and Prospective Proposition
Journal of the American College of Radiology
Bradley Merrill Thompson

February 27, 2015 – Article
In-Depth: Anticipating FDA Regulation of Pharmaceutical Apps
MobiHealthNews
Bradley Merrill Thompson

January 16, 2015 – Article
The LDT Debate: Understanding FDA’s Jurisdiction Over IVDs Made at a Clinical Lab
Pharma MedTech Insights Blog
Bradley Merrill Thompson


December 5, 2014 – Article
Healthcare, Poverty, and Technology: Connecting the Dots
Medical Device and Diagnostic Industry
Bradley Merrill Thompson


November 14, 2014 – Article
What’s in the Shoe Box?
Gospel Justice Initiative
Bradley Merrill Thompson


October 31, 2014 – Article

Gospel Justice Initiative

Bradley Merrill Thompson


October 10, 2014 – Article

Gospel Justice Initiative

Bradley Merrill Thompson


September 19, 2014 – Article

Gospel Justice Initiative

Bradley Merrill Thompson


August 1, 2014 – Article
MMA Roadshow: 10 Lessons for Developers
Journal of mHealth
Bradley Merrill Thompson


April 12, 2014 – Article
International Guidance on Regulating Software as a Device Could Influence U.S. Oversight, in Bloomberg BNA’s Health IT Law & Industry Report
Bradley Merrill Thompson


April 8, 2014 – Article
Analysis: The Significance and Insignificance of the FDASIA HIT Report, in mHealthNews
Bradley Merrill Thompson


March 28, 2014 – Article
Medical Device and Diagnostic Industry
Bradley Merrill Thompson


March 20, 2014 – Article
Lessons from McKesson: Insight into FDA’s Stance on Clinical Decision-Support Software, in Medical Device and Diagnostic Industry
Bradley Merrill Thompson


March 14, 2014 – Article
Evenhanded FDA Enforcement, in Medical Device and Diagnostic Industry
Bradley Merrill Thompson


March 3, 2014 – Article
How the FDA Can Improve Regulation of Mobile Health, According to FDASIA Workgroup, in MobiHealthNews
Bradley Merrill Thompson


February 12, 2014 – Article
8 Types of Medical Apps a Senate Bill Asks FDA to Stop Regulating, in Mobihealthnews
Bradley Merrill Thompson


November 11, 2013 – Article
E-book: FDA Regulation of Mobile Health 2013 (Second Edition) (MobiHealthNews)
Bradley Merrill Thompson


September 30, 2013 – Article
MobiHealthNews.com

Bradley Merrill Thompson


September 24, 2013 – Article
FDA (Finally) Returns Industry’s Calls for Mobile Medical Apps Guidance, in Medical Device and Diagnostic Industry
Bradley Merrill Thompson


September 4, 2013 – Article
Part 2: Set FDA’s Mobile Medical App Guidance Free, on MobihealthNews.com
Bradley Merrill Thompson


August 29, 2013 – Article
BMJ.com

Bradley Merrill Thompson


August 27, 2013 – Article
Set the FDA Mobile Medical App Guidance Free, on MobihealthNews.com
Bradley Merrill Thompson


May 25, 2013 – Article
Three Reasons FDA’s Enforcement Helps Mobile Health, in Mobihealthnews.com
Bradley Merrill Thompson


May 8, 2013 – Article
American Telemedicine Association Annual Meeting Connects At-Risk Patients to Specialists and Home Aging, in Medical Device and Diagnostic Industry
Bradley Merrill Thompson


May 1, 2013 – Article
Managing Your Business Risk in Mobile Health: Part 2, in Mobihealthnews.com
Bradley Merrill Thompson


April 29, 2013 – Article
Counting Our Blessings with the Office of Combination Products, in Medical Device and Diagnostic Industry
Bradley Merrill Thompson


April 24, 2013 – Article
Managing Business Risk in Mobile Health: Part 1, in Mobihealthnews
Bradley Merrill Thompson


April 15, 2013 – Article
International Regulators Focus on Medical Software, Including Apps, in Mobihealthnews
Bradley Merrill Thompson


March 26, 2013 – Article

Bradley Merrill Thompson


March 13, 2013 – Article

Bradley Merrill Thompson


March 1, 2013 – Article

Bradley Merrill Thompson, M. Jason Brooke


June 20, 2012 – Article

Bradley Merrill Thompson


March 14, 2012 – Article

Bradley Merrill Thompson


December 28, 2011 – Article

Bradley Merrill Thompson


October 17, 2011 – Article

Bradley Merrill Thompson


September 19, 2011 – Article

Bradley Merrill Thompson


August 31, 2011 – Article

Bradley Merrill Thompson


May 15, 2011 – Article

Bradley Merrill Thompson


March 15, 2011 – Article

Bradley Merrill Thompson


February 15, 2011 – Article
MobiHealthNews.com
Bradley Merrill Thompson


December 29, 2010 – Article

Bradley Merrill Thompson


June 30, 2010 – Article

Bradley Merrill Thompson


June 1, 2010 – Article
MobiHealthNews.com
Bradley Merrill Thompson


April 19, 2010 – Article

MobiHealthNews.com
Bradley Merrill Thompson


April 8, 2010 – Article

Bradley Merrill Thompson


March 23, 2010 – Article

Bradley Merrill Thompson


February 26, 2010 – Article

Bradley Merrill Thompson


February 9, 2010 – Newsletters


January 14, 2010 – Article

Bradley Merrill Thompson


December 1, 2009 – Article

Bradley Merrill Thompson


November 30, 2009 – Newsletters


October 30, 2009 – Newsletters


October 2, 2009 – Article

Bradley Merrill Thompson, Leah R. Kendall


September 23, 2009 – Article

Bradley Merrill Thompson


September 1, 2009 – Newsletters


August 24, 2009 – Article
MobiHealthNews.com

Bradley Merrill Thompson


July 31, 2009 – Newsletters


July 13, 2009 – Article

Bradley Merrill Thompson


May 8, 2009 – Client Alerts


April 30, 2009 – Newsletters


March 31, 2009 – Newsletters


February 28, 2009 – Newsletters


January 31, 2009 – Newsletters


December 4, 2008 – Newsletters


October 1, 2008 – Article
Off-Label Communications: A Guide to Sales and Marketing Compliance
Bradley Merrill Thompson


August 1, 2008 – Article

Bradley Merrill Thompson


March 31, 2008 – Article
An Uncertain Path: A New Survey Indicates Industry’s Desire for More Detailed Guidance for Developing and Commercialing Combination Products, in MX Magazine
Bradley Merrill Thompson


July 15, 2005 – Article

Bradley Merrill Thompson


March 1, 2004 – Article
The IVAT Solution, IVD Technology
Bradley Merrill Thompson


March 1, 2004 – Article
Measuring Compliance
Bradley Merrill Thompson


November 1, 2002 – Article
The FDA Approval and Medicare Coverage Processes, Part 2: Striving Toward Harmonization
Bradley Merrill Thompson


September 1, 2002 – Article
The FDA Approval and Medicare Coverage Processes, Part 1: Current Interconnections
Bradley Merrill Thompson


January 1, 2002 – Article

Bradley Merrill Thompson


June 1, 1998 – Article
Health Care Industry Working Group Develops Draft PE Guidance, FDA Advertising and Promotion Manual 4
Bradley Merrill Thompson


May 1, 1998 – Article
CLIA Reform: Present and Future, IVD Technology
Bradley Merrill Thompson


February 1, 1998 – Article
Medical Devices in China, 6 The Regulatory Affairs Journal 25
Bradley Merrill Thompson


November 1, 1997 – Article
The Product Development Protocol, Vol. 2, No. 11, RA Focus
Bradley Merrill Thompson


May 1, 1996 – Article
The Demise of Rule Making and the Rise of Guidances, 18 Medical Device & Diagnostic Industry 99
Bradley Merrill Thompson


January 1, 1995 – Article
Book: FDA Regulation of Medical Devices (Interpharm Press)
Bradley Merrill Thompson


August 1, 1994 – Article
510(k)s for Sale, 16 Medical Device & Diagnostic Industry 34
Bradley Merrill Thompson


January 1, 1994 – Article
Keeping Track of Medical Devices, 11 Food, Drug, Cosmetic and Medical Device Law Digest 24
Bradley Merrill Thompson


May 1, 1993 – Article
Companies Should Police Themselves, Indiana Business Magazine 91
Bradley Merrill Thompson


May 1, 1993 – Article
FDA’s Expanding Definition of Diagnostic Devices, 15 Medical Device & Diagnostic Industry 58
Bradley Merrill Thompson


September 1, 1992 – Article
FDA’s New and Improved Approach to Device Tracking, 14 Medical Device & Diagnostic Industry 66
Bradley Merrill Thompson


January 1, 1992 – Article
FDA’s New Rules for Investigational and Research IVDs, 4 Regulatory Affairs 305
Bradley Merrill Thompson


January 1, 1991 – Article
Resurrecting the Product Development Protocol for Medical Devices, 46 Food Drug Cosmetic Law Journal
Bradley Merrill Thompson


August 27, 1990 – Article
Tax Savings for Small Exporters, Vol. 11, No. 20, Indianapolis Business Journal
Bradley Merrill Thompson


August 1, 1990 – Article
Lifting the Burden of IDE Regulations Off Device Feasibility Studies, Medical Device & Diagnostic Industry
Bradley Merrill Thompson


September 11, 1989 – Article
Some Tips for Protecting the Confidentiality of an Environmental Audit, Vol. 10, No. 22, Indianapolis Business Journal
Bradley Merrill Thompson


January 1, 1988 – Article
FDA’s Candid Camera, 43 Food Drug Cosmetic Law Journal 335
Bradley Merrill Thompson


January 1, 1988 – Article
Companies Must Weigh Competing Interests in Planning for FDA Inspection, Vol. 8, No. 52, Indianapolis Business Journal
Bradley Merrill Thompson


January 1, 1983 – Article
Research and Development Strategies: Competitive Implications for American Firms, Outstanding Papers
Bradley Merrill Thompson