Regulatory and Legal
FDA Endorses Agile: What Does that Mean?
May 21, 2013
In January of 2013, the wishes of Agile fans writing software for medical devices finally came true—FDA added AAMI TIR45:2012, “Guidance on the use...
Court Upholds FDA in Menaflex Case
May 14, 2013
FDA acted properly and within its statutory authority when it reclassified ReGen Biologics Menaflex knee repair device and rescinded the company’s 510(k...
Guidance on Device Classification Product Codes
May 14, 2013
 FDA has finalized guidance on medical device classification product codes that are used to assist in accurate identification and tracking of current...
Andrew Ekdahl's Role in DePuy Orthopedics Hip Recall Litigation
May 09, 2013
It’s only been a few years since DePuy put Andrew Ekdahl in the president’s chair. Before that, the 20-year veteran had most recently served as...
Share Intellectual Property, Ex-FDA Chief Says
May 08, 2013
Former FDA commissioner Andrew von Eschenbach thinks medical device and diagnostic companies should be collaborating and sharing intellectual property to...
CDRH Ponders Ways IDEs Can Boost Innovation
May 08, 2013
CDRH is considering how it might rebalance its evaluation of risk/benefit factors in the review process for some medical devices, according to CDRH’s...
Another Classification Kerfuffle at FDA
Apr 30, 2013
In the 2012 FDA Safety and Innovation Act enacted last summer, FDA managed to persuade Congress give it new administrative-order authority over the...
The Current and Future State of Medtech in India
Apr 04, 2013
Brazil, Russia, India, and China, collectively known as the BRIC countries, are the largest players in the medical device arena, following the United States,...
Pope Francis Repeals Medical Device Tax
Apr 01, 2013
 Mere weeks after his election, Pope Francis is making his voice heard on a number of foreign and domestic affairs. However, many were still surprised...
Medical Device Tax in Jeopardy After Senate Votes to Repeal
Mar 22, 2013
Late Thursday night the Senate voted to an overwhelming 79-20 tally to repeal the medical device tax.The vote included 33 Democrats who voted alongside...