Medical devices cleared under the US Food and Drug Administration’s premarket approval (PMA) pathway are more likely to undergo a recall if their manufacturers have filed additional documentation with ...
On February 20, the U.S. Supreme Court handed Medtronic Inc. (Minneapolis) a resounding victory in a much-watched and long-fought product liability dispute. In issuing their landmark decision, the ...
The medical device amendments state the principal that federal rules preempt requirements established under state law (Sec. 360k(a)). This express preemption clause provides, in part, that no state ...
MOUNT LAUREL, NJ - (NewMediaWire) - June 24, 2024 - United Health Products, Inc. (OTCPK: UEEC) today provided an update on the company's FDA Premarket Approval (PMA) application process. Following the ...
The Government Accountability Office recently chastised the FDA for not moving fast enough in implementing stricter regulationsin approving Class III medical devices. In January, the Government ...
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