How does the concept of "different technological characteristics" impact the determination of substantial equivalence?

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The US Food and Drug Administration (FDA) cleared the disc via the 510(k) pathway, which does not require clinical testing data. Instead, clearance is based on ... Dec 22, 2021 ... The FDA clearance is based on data from multiple studies of the ... mean tear film breakup time and meibomian gland secretion score ... Pending 510(k) clearance, not available for sale within the United States. Check out our next-generation MRI!! Page 11. □ “FDA does not intend to object to” ... Oct 24, 2023 ... 510(k) clearance is the FDA's primary regulatory process. It is ... This means that the current state of the art is no longer guaranteed. TPRG specializes in the review of 510(k) submissions, providing you with efficient FDA clearance. The Third Party Review Group is the expert in 510K TPR ... Jan 10, 2023 ... Main Outcomes and Measures Class I or class II recall of a 510(k) medical device between its FDA regulatory clearance date and December 31, 2020 ... Nov 13, 2024 ... It includes the latest features used in molecular imaging and simplifies workflows significantly. This is a new milestone in NM Processing and ... Oct 4, 2023 ... Anumana's ECG-AI LEF is an innovative software-as-a-medical device (SaMD) designed to screen for LEF in adults at risk for heart failure. Jan 24, 2023 ... What does this all mean for you? It means we did the work to ... What that means: A 510(k) filing contains detailed technical, safety ... Oct 21, 2021 ... The Premarket Notification, or 510(k) submission, is the mechanism through which the majority of medical devices obtain US marketing clearance.
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