Regulatory/Legal
This Week in Devices: [3/30/12]: Supreme Court vs. Healthcare Reform, Consumer Reports is mad at the FDA, Thomas Fogarty to Receive MDEA Lifetime Achievement Award
Mar 30, 2012
Supreme Court Hearings on Healthcare Reform The U.S. Supreme Court concluded three days of hearing arguments on the constitutionality of President Obama's...
Op Ed: The 60601-1 Third Edition Is Not Mandatory
Feb 07, 2012
Almost every day, another advertisement or article is released that espouses the need to get ready for product testing to the new IEC 60601-1 Third Edition....
5 Questions About Device-Drug Combo Products
Feb 03, 2012
Mark Kramer answers 5 questions on combination products and the regulatory hurdles manufacturers can face. 1. What is a combination product? A combination...
How Will the Sunshine Act Affect Medical Device Companies?
Jan 30, 2012
Loading... Further Reading: Who Paid for Your Doctor's Bagel?  
File Early, File Often, and Other Intellectual Property Advice
Jan 19, 2012
MD+DI has three new features dedicated to intellectual property. The first new feature is the first in a series on the impact of patent reform on medical...
The Medtech Leader Perspective on Globalization at OneMedPlace Conference
Jan 11, 2012
The OneMedPlace finance conference in San Francisco featured a panel discussion titled "AdvaMed 2012 CEO’s Unplugged: Global Outlook on Medical...
Point and Counterpoint on the Device Tax
Jan 11, 2012
There is a lively debate going on in the Medical Devices Group on LinkedIn, which just reached a milestone of 80, 000 members. The topic up for discussion is...
When Reason Meets the Absurd: A Quick Look at FDA and CDRH in 2011
Dec 18, 2011
While FDA (CDRH) and the medical device industry have a long history of antagonism, the relationship seemed to become especially sour in 2011. The agency has...
The Medtech Industry’s PR Problem
Dec 14, 2011
Not too long ago—a few decades to be somewhat imprecise, the healthcare industry in the United States was much less regulated than it is today, and was...
Misunderstanding of FDA Device Classification Is Widespread
Dec 09, 2011
The device classification scheme is an important component of the U.S. regulatory system for medical technology. Introduced in the Medical Device...