Regulatory/Legal
Aug 15, 2006
FDA announced that on October 10 it will hold a public meeting on FDA-regulated products containing nanotechnology materials. The agency wants to learn what...
Aug 11, 2006
FDA has issued a statement in response to a recent Journal of the American Medical Association article on recalls and safety alerts involving automatic...
Aug 09, 2006
FDA is one step closer to requiring bar coding or other forms of unique identification on medical devices. On Friday it will publish in the Federal Register a...
Aug 07, 2006
The Bush Administration plans to launch an ambitious standards effort that could boost the use of information technology in hospitals. According to the...
Aug 03, 2006
FDA has released the FY 2007 user fee structure as per MDUFMA and MDUFSA. The PMA fee will increase to $281,600, a jump of almost 8.5%, the maximum allowed...
Aug 02, 2006
CMS announced that it will not implement a plan that would have made major cuts in reimbursement for heart-repair procedures and defibrillator implants. A...
Jul 31, 2006
The Federal Trade Commission has issued a public advisory notice urging consumers to be cautious when purchasing at-home genetic tests. Citing statements and...
Jul 27, 2006
It seems that the campaign by device companies and hospitals to convince CMS to revise its controversial reimbursement plan are paying off. The Hill reports...
Jul 20, 2006
Several potentially significant products have received FDA approval this week: Medtronic won clearance for its Guardian REAL-Time continuous glucose...
Jul 19, 2006
Industry giant Medtronic Inc. yesterday agreed to pay the federal government $40 million to settle accusations that its spinal unit, Medtronic Sofamor Danek,...