What's Important in Assessing the Need for Additional 510(k) Clearance for Medical Device Changes?

Medical device companies often find themselves in a bind if the U.S. Food and Drug Administration (FDA) scrutinizes their decisions that product changes did not trigger the regulatory requirement for a new 510(k) submission for the changed device. Th…

Abraham Lincoln’s Convention: Chicago 1860, by Kenneth D. Ackerman...Now Available!

Abraham Lincoln’s Convention: Chicago 1860, compiled and presented by OFW Law’s very own Kenneth D. Ackerman, is now available!  An eBook original and part of a series called History Shorts/Original Voices, it tells the story of Lincoln’…

John Block Reports: A Visit to St. Petersburg / Back in the USSR

OFW Law founding principal Richard L. Frank fills in for former USDA Secretary John R. Block on John Block Reports. We just returned from summer vacation to the Baltic, including St. Petersburg, Russia. Mother Russia hasn’t really changed all t…

John Block Reports: Tabloid Journalism – ABC News Slimes Lean Beef

OFW Law founding principal Richard L. Frank fills in for former USDA Secretary John R. Block on John Block Reports. Reaching new lows in broadcast television journalism, ABC News several weeks ago ran an investigative report unfairly and inaccura…

John Block Reports: The Case for Obama

OFW Law founding principal Richard L. Frank fills in for former USDA Secretary John R. Block on John Block Reports. Remember, I’m Jack’s moderate Democrat colleague. We support the same priorities – a healthy and prosperous agricultural sec…

John Block Reports: Pain and Productivity

OFW Law founding principal Richard L. Frank fills in for former USDA Secretary John R. Block on John Block Reports. The bad news just keeps rolling in. The unemployment rate rests at 9% with over 400,000 new applicants each week. Worse yet, many…

John Block Reports: Holiday in Europe – Food Safety Gets Personal

OFW Law founding principal Richard L. Frank fills in for former USDA Secretary John R. Block on John Block Reports. Over the past 35 years, I have acted as food safety counsel to a wide array of agriculture interests in the United States includin…

John Block Reports: Don’t Cut the FDA Budget

OFW Law founding principal Richard L. Frank fills in for former USDA Secretary John R. Block on John Block Reports. Recently, Congress enacted new laws to bolster food safety and to require calorie labeling for restaurant foods. Both of these law…

John Block Reports: Food Safety Legislation Enhances Already Safe Food Supply

OFW Law founding principal Richard L. Frank fills in for former USDA Secretary John R. Block on John Block Reports. Last week the President signed the Food Safety Modernization Act. It was passed by a united lame-duck Congress in the waning days…

John Block Reports: Time for Leadership

OFW Law founding principal Richard L. Frank sits in with former USDA Secretary John R. Block on John Block Reports. The election is now over. Yes, Republicans have made significant gains, reclaiming the House and gaining a virtual tie in the Se…

Disclaimer:

Ag/FDA Blog is the blog of Olsson Frank Weeda Terman Matz PC (“OFW Law”). The contents of this blog are published for informational purposes only. Publication and use of this blog does not create an attorney-client relationship with the reader nor should the information herein be construed as legal advice. Readers should be aware that OFW Law represents many companies and organizations in the agriculture, food, drug, medical device, health care and other industries, and, therefore, Ag/FDA Blog may occasionally report on news that relates to OFW Law’s clients. No part of Ag/FDA Blog – whether information, commentary, or other – may be attributed to OFW Law’s clients.

Case results depend upon a variety of factors unique to each case and any prior case results provided on this blog do not guarantee a similar result in any future case undertaken by OFW Law.

Copyright 2012 Olsson Frank Weeda Terman Matz PC

For technical questions about the Ag/FDA Blog, please e-mail Peter Matz at pmatz@ofwlaw.com.