FDA: Michigan Heart-lung Bypass Machine Manufacturer Enters Into Consent Decree
The U.S. Food and Drug Administration announced that Terumo Cardiovascular Systems Corporation (TCVS) of Ann Arbor, Mich., and two of its officers, Mark A. Sutter, president and chief executive officer, and Mark Lincoln, vice president of Quality Assurance and Operations, have signed a consent decree of permanent injunction. The consent decree, to be filed in the U.S...

FDA lifts warnings against 2 Medtronic plants, clearing way for new product approvals
WASHINGTON - Medtronic Inc., the world's largest medical device company, said Wednesday it has resolved two warning letters from the Food and Drug Administration over lax oversight at two manufacturing plants, clearing the way for new product approvals.

Speed of FDA approvals a starting point for new Congressional review
FDA approvals are going to remain an issues for medical device manufacturers. Congressional leaders reviewing the Medical Device User Fee and Modernization Act say recent reforms have been overstated and that concerns over safety and increased scrutiny are wrongheaded.