FDA Reviews Medical Device Approval Program After Criticism
the FDA has issued new guidance for its 510(k) fast track medical device approval process, seeking to better define which devices qualify for the controversial program.…
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the FDA has issued new guidance for its 510(k) fast track medical device approval process, seeking to better define which devices qualify for the controversial program.…
Recently proposed legislation would make it illegal for corporate officers to cover up dangerous product defects or drug side effects, putting in place fines and jail terms for executives.…
More than 6,600 emergency cricothyrotomy kits were recalled last week due to possible defective cuffs that could lead to patient injuries.…
Consumer watchdogs are asking the Federal Trade Commission to step in and take action against a company that makes portable bed rails, indicating that that they are dangerous and falsely advertised.…
As part of the continuing fallout from a recent Supreme Court decision that prevents consumers from holding generic drug makers responsible for dangerous and defective medications they sell, all federal lawsuits over femur fractures caused by Fosamax generic equivalents will be dismissed.…
About 10,000 Schwinn 460 Elliptical Exercise Trainers by Nautilus have been recalled after reports of problems where the foot plates may break or detach, causing the users to fall off the exercise machine while working out. …
About 2,500 Ballard Designs step stools have been recalled after consumers reported instability, falls and minor injuries. …
An Alabama man has filed a product liability lawsuit over problems with a Smith & Nephew Journey knee, alleging that his artificial knee failed when a recalled tibial baseplate fractured.…
About 304,000 Chefmate blenders sold by Target have been recalled after a number of consumers suffered serious hand and finger injuries when the pitcher unexpectedly came apart from the blade assembly. …
A Michigan man has filed a product liability lawsuit that indicates his Wright Profemur hip replacement failed less than three years after being implanted, when the femoral neck of the hip implant broke. …