FDA Insights

March 2008
Medical Device Labeling

June 2007
Why Are There So Few Vascular Stents Approved?

November 2006
Conflicts of Interest

September 2006
Results Using the PolarCath Peripheral Dilatation System and Sterling PTA Balloon Dilatation Catheter

June 2006
Medical Device Reporting

May 2006
Elements of a Good Animal Study

April 2006
Standardized Objective Performance Criteria and Control Datasets

March 2006
MR Safety of Cardiovascular Implants

Febraury 2006
How You Can Prevent Poor Data

November 2005
FDA Insights: Regulation of Peripheral Vascular Devices

October 2005
FDA Insights: Providing a Reasonable Assurance of Safety and Effectiveness

August 2005
Regulation of Peripheral Vascular Devices

July 2005
CAS Approval and Reimbursement

May 2005
Custom Devices

March 2005
Exhibit Halls

February 2005
Inside the Gore TAG Device Advisory Hearing

November/December 2004
Live Cases Involving Investigational Devices

October 2004
The Preclinical Testing of Endovascular Grafts

September 2004
FDA Approval of Carotid Artery Stenting

July/August 2004
IDE Progress Reports

June 2004
Optimizing Registry Data Presentation

May 2004
The Cordis Carotid Stent System Panel Hearing

April 2004
Premarket Approval and Premarket Notification

March 2004
What the CDRH Doesn't Do

February 2004
How to (Or Not to) Impede FDA Reviews

January 2004
What to Expect When You Are Inspected

November/December 2003
Top 10 Issues and Insights for Endovascular Grafts

October 2003
Medical Device User Fee and Modernization Act

September 2003
Crime and Punishment

July/August 2003
The ISO Standard for Endovascular Graft

May/June 2003
The FDA Medical Device Fellowship Program

April 2003
Expanded Access

March 2003
Off-Label Medical Device Use

January/February 2003
Investigational Device Exemptions

November/December 2002
What exactly are you up against–and why?

September/October 2002
Medical Device Approval in the US and Abroad