Regulatory/Legal
Jul 13, 2012
 This Week in Devices [7/13/12] President Obama Signs Food and Drug Administration Safety and Innovation Act The President's has signed the bipartisan...
Jul 11, 2012
UPDATE: On 13 July 2012 IEC formally published the long awaited IEC 60601-1:05 (also known as third edition) Amendment 1 (A1).  It is on the IEC.ch...
Jul 02, 2012
Larry Spears is director, Health Sciences Industry, Deloitte and Touche, LLP and former CDRH Deputy Director for Regulatory Affairs. We asked him to draw on...
Jun 29, 2012
 This Week in Medical Devices [6/29/12] Supreme Court Upholds Affordable Care Act The Supreme Court laid down its decision on the Affordable Care Act and...
Jun 28, 2012
The Supreme Court this morning upheld most of President Obama’s Patient Protection and Affordable Care Act (ACA), a decision that means the medical...
Jun 08, 2012
This Week in Devices: [6/8/2012] House Repeals Medical Device Tax Ding-dong the tax is dead! At least in the House of Representatives as Republicans and...
May 15, 2012
  Christy Foreman, director of the Office of Device Evaluation at CDRH As director of the Office of Device Evaluation (ODE) at CDRH, Christy...
May 07, 2012
The Corporate Whistle Blower Center is encouraging representatives of the medical device industry to step forward if they believe their company is actively...
May 01, 2012
1. Why does FDA require validation of spreadsheets and databases? To put it simply, the purpose of validating any software or computerized system is to...
Apr 06, 2012
  MDEA Finalists Announced   The finalists of the 2012 MDEA Competition can be viewed at MDDIOnline.com    Google’s Project Glass...