Regulatory/Legal
Medicare Payment Cut Proposals Raise Industry Ire
Apr 14, 2006
Proposed changes in the Medicare payment structure could produce drastic cuts in reimbursement for high-priced procedures such as implanting stents and...
Diagnostics Arena Changing, For Better and Worse
Apr 13, 2006
This morning's New York Times has an extensive article on the new wave of genomic-based diagnostic tests. The new territories they can explore in diagnostics...
EU Approves Boston Scientific-Guidant Deal
Apr 12, 2006
Only one hurdle remains for the largest deal in device-industry history to go through. European Union regulators have approved Boston Scientific Corp.'s $27...
Soft Contact Lenses Can Cause Serious Infections, Officials Say
Apr 11, 2006
FDA and the Centers for Disease Control and Prevention have sent out a public health notice warning of increasing reports of a serious fungal infection caused...
Bill Would Reduce Liability for Defibrillator Use
Apr 10, 2006
Some believe that external defibrillators aren't in more public places because of fear of lawsuits over misuse. That fear may be alleviated in Canada's largest...
CDRH to Use Outside Experts for Postmarket Safety Issues
Apr 07, 2006
CDRH has used outside experts to help it review products during the approval process. But it has never used them for help on postmarket issues until now. The...
FDA Hires Consultant to Evaluate Postmarket Practices
Apr 06, 2006
FDA has awarded a contract to Booz Allen Hamilton to evaluate the postmarket study commitment process. The hoped-for outcome is greater consistency among the...
ITC Investigates Global Competition
Apr 05, 2006
On April 3, Congress requested that the U.S. International Trade Commission investigate the effects of foreign market competition on U.S. medical device and...
Reevaluation in the Cards for FDA
Mar 31, 2006
MD...
OSEL Annual Report Highlights Connections to FDA's Mission
Mar 28, 2006
CDRH's Office of Science and Engineering Laboratories (OSEL) today released its annual report for Fiscal Year 2005. OSEL supports the scientific basis for FDAâ...