FDA classifies medical devices based on the type of device and the level of risk it poses Three main FDA clearances for medical devices are 510(k), de novo and pre-market approval Several ASX ...
The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...
A recent preemption decision out of the Southern District of New York offers encouraging news for medical device manufacturers. In Wieder v. Advanced Bionics LLC, 2025 WL 3237257 (S.D.N.Y. Nov. 20, ...
In the United States, medical device regulation and intellectual property (IP) protection are governed by complex statutory and regulatory frameworks that are distinct from—but closely related to, and ...
The market opportunity lies in providing solutions and services for global medical device companies to comply with US FDA and EU MDR post-market surveillance and complaint handling requirements. This ...
GAITHERSBURG, MD — Instrumentation used to place surgical mesh during urogynecological procedures should be subject to stricter manufacturing requirements and more detailed labeling, according to US ...
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