Moving From Substantial Equivalence to Substantial Improvement for 510(k) Devices – ScienceOpen
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      Moving From Substantial Equivalence to Substantial Improvement for 510(k) Devices

      1 , 2 , 3 , 1 , 4
      JAMA
      American Medical Association (AMA)

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          Need for a National Evaluation System for Health Technology

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            Assessing the safety and effectiveness of devices after US Food and Drug Administration approval: FDA-mandated postapproval studies.

            Postmarketing surveillance is critical to evaluating the safety and effectiveness of medical devices. The US Food and Drug Administration (FDA) may order the manufacturer of a high-risk device to conduct postmarketing surveillance studies, known as postapproval studies (PASs), at the time of approval.
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              Author and article information

              Journal
              JAMA
              JAMA
              American Medical Association (AMA)
              0098-7484
              September 10 2019
              September 10 2019
              : 322
              : 10
              : 927
              Affiliations
              [1 ]UCSF School of Medicine, San Francisco, California
              [2 ]Philip R. Lee Institute for Health Policy Studies, San Francisco, California
              [3 ]Editor, JAMA Internal Medicine
              [4 ]San Francisco Veterans Affairs Medical Center, San Francisco, California
              Article
              10.1001/jama.2019.10191
              31355877
              4979eb1b-de36-487f-8cf7-3f9309aaf62d
              © 2019
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