Regulatory/Legal
IEC to Issue Amendment 1 to 60601-1, 3rd Edition Medical Electrical Equipment Standard
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...
5 Questions on Regulatory Expectations for Management with Larry Spears
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...
This Week in Medical Devices [6/29/12]: Supreme Court Rules on Obamacare and Breakthroughs Aplenty in Cancer Treatment, Transplant Surgery, and Cardiology.
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...
SCOTUS Upholds Affordable Care Act; Device Tax Continues to be a Worry
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...
This Week In Devices - [6/8/12]: House Repeals Medical Tax; RIP Ray Bradbury; Choose Wisely Asks Patients to Rethink Healthcare
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...
Women in Medtech: FDA’s Christy Foreman Urges Students to Find a Mentor
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...
Corporate Whistle Blower Center Goes After Medical Device Industry
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...
5 Questions with Denise Dion: Vallidation Spreadsheets and Databases
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...
This Week in Devices [4/6/2012]: MDEA Finalists Announced; Google’s Project Glass; Virtual Dissection; What if Your Home was a Medical Device?
Apr 06, 2012
  MDEA Finalists Announced   The finalists of the 2012 MDEA Competition can be viewed at MDDIOnline.com    Google’s Project Glass...
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...