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 ...
PMA, and DeNovo submissions to bring medical devices to the US market. Recent 510(k) modifications for new technologies and safety advancements, along with AI integration, present significant ...
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 Government Accountability Office (GAO) is urging the U.S. Food and Drug Administration (FDA) to use the most stringent pre-market review process in approving high-risk medical devices, according ...
Definitive One Year Data from PMA Application to be Presented Wednesday at 51st Annual VEITH Symposium Company to Host a Conference Call with the PIs Presenting the Pivotal Trial Data on Wednesday, ...
Company to Host a Conference Call with the PIs Presenting the Pivotal Trial Data on Wednesday, November 20th at 2:00 PM Eastern Time - Click Here to Access IRVINE, CA / ACCESSWIRE / November 19, 2024 ...
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