While the overall percentage of medical devices approved and recalled by the US Food and Drug Administration (FDA) is relatively low, the recent increase in recalls for devices approved via the 510(k) ...
MESQUITE, NV, June 07, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire – United Health Products, Inc. (UEEC) today provided an update on the company’s FDA Premarket Approval application process. As ...
Allison Zieve, arguing on behalf of the petitioner, began by discussing the PMA process and stressing what PMA is and what it isn’t. Notably, Ms. Zieve argued, the FDA grants the PMA if the ...
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 ...
Dublin, Jan. 30, 2026 (GLOBE NEWSWIRE) -- The "Understanding Medical Device Regulatory Pathways - 510(k), PMA & Exemptions (January 15, 2026)" training has been added to ResearchAndMarkets.com's ...
August 6, 2010 (Silver Spring, Maryland) — As the Institute of Medicine continues its review of the FDA's 510(k) clearance process for devices that do not require full premarket approval (PMA) review, ...
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