Licensure

Position

News

• Judge rejects plea agreement in Guidant defibrillator case
  Apr 28, 2010 — Pioneer Press
  Robert Hauser and Barry Maron went public with their concerns in 2005 after the death of their 21-year-old patient Joshua Oukrop. The defibrillator business is especially important in the Twin Cities, which is home to Boston Scientific's unit for heart rhythm devices and corporate headquarters for rival manufacturers Medtronic (NYSE:MDT) and St. This is not necessarily always the case." In an interview Tuesday, Hauser said he generally agreed with the judge's sentiments.
• Med-tech group wary of changes that slow FDA process
  Apr 22, 2010 — Star Tribune
  Jeffrey Shuren on April 9 to discuss impending changes at the FDA, which regulates medical devices. But the FDA may forge ahead with changes before then. Shuren will travel to Minneapolis -- a national hub for med-tech -- May 18 for a town meeting to discuss possible changes to the 510(k) process.
• A kid-sized niche
  Jan 29, 2010 — Star Tribune
  In 2007, the Food and Drug Administration announced a $2 million annual grant program to spur innovation of pediatric devices. Thomas, which came up with engineering plans for the OPOD device. Cloud State University specializing in FDA medical device regulations crafted a plan for the OPOD to gain regulatory approval.
• Watchdog Bush FDA decision put patients in danger
  Feb 18, 2009 — McClatchy Washington Bureau
  ...many inspections specific to GLP as we have in the past. We continue to review our inspectional plans, and (the agency) maintains the authority to request additional information on GLP adherence from a manufacturer and inspect any facility for GLP compliance." In a letter to POGO in May, Casper Uldriks, the head of regulatory guidance for the FDA's Center for Medical Devices and Radiological Health, said the FDA's enforcement is adequate. Uldriks noted that the agency requires...