FDA Lifts Restrictions on Boston Scientific Minnesota Guidant Plant
April 19, 2007 16:51

http://biotech.seekingalpha.com/article/32469The FDA has cleared its St. Paul cardiac rhythm-management device plant for operation. The plant was originally owned by Guidant, which Boston Scientific purchased for $27.5 billion last year. Guidant recalled 109,000... (Read Article)

Guidant and medical devices
April 20, 2007 16:49

Implantable medical devices seized in New Jersey because of sterility scare - http://www.komotv.com/news/health/7082141.htmlU.S. marshals and FDA investigators began seizing heart valves and other implantable medical devices made from cow and pig tissue by... (Read Article)

FDA Proposes Medical Device User Fee
April 20, 2007 16:52

http://compliancehome.com/news/FDA/10506.html

The FDA proposed recommendations to Congress for reauthorizing the Medical Device User Fee and Modernization Act (MDUFMA II), which, if adopted, would help to ensure that safe and effective medical devices get to patients in a timely manner. FDA is accepting public comments on the proposal for the next 30 days and is holding a public meeting on April 30.

Under the medical device user fee program, industry covers a portion of the costs of FDA's pre-market review program through a variety of fees. The fees are used to help FDA meet its review performance goals, which would speed more promising products to market than before.

Manufacturers would continue to pay fees when they submit applications for some types of medical device applications, but at a lower rate than under the current program. The additional revenues generated from fees paid by the medical device industry would continue to be used to ensure patients have timely access to safe and effective medical devices.