A potentially deadly short-circuiting problem with implantable defibrillators made by the former Guidant Corp. may be far more common than initially indicated, according to an analysis by federal regulators. Guidant's implantable heart devices may fail about 10 times more often than the company had projected last year, according to a U.S. Food and Drug Administration analysis released in a Texas lawsuit. A judge in a product-liability lawsuit involving Guidant's defibrillators recently unsealed the FDA document dated June 16, 2005. Pioneer Press (http://www.twincities.com/mld/twincities/14880994.htm)
Simplifying Global Compliance
Recommended Products
EU MDR Compliance: A Checklist for Meeting Manufacturing, Safety and Performance Requirements
The FDAnews report EU MDR Compliance can help. Our editors have combed through the regulations, picking out the most minute compliance points and building them into a checklist of 200+ requirements you can use to confirm that you are satisfying all the EU mandates for device manufacturing.
Accelerating Generic Drug Development: The FDA’s New Plan for Increasing Generic Competition
Accelerating Generic Drug Development explains the FDA’s new policy and shows how to navigate the new pathway to approval.
Editor's Picks
FDA Issues Warning Over Unapproved Breast Implant Device
The FDA said that the surgeon has been advertising the unapproved device on his web site.
FDA Recognizes Polish, Slovenian Inspections
Regulators on both sides of the Atlantic are optimistic they’ll meet the deadline, which they hope will allow them to direct more inspection resources elsewhere.
