What is it about?
The focus of this text is to differentiate the application of medical device regulatory legal requirements of the United States Food & Drug Administration for premarketing stakeholders, such as original equipment manufacturers, and the specific instances where regulatory controls impact device user facilities. We note some particular circumstances, such as the sale or lending of a 510(k), that fall in between the distinction of premarketing and postmarketing activities.
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Why is it important?
The document also examines the specific risks associated with medical device off-label use and modifications as well as the conflict of interest posed by the discoverability of adverse event reporting for device user facilities.
Perspectives
Ch 13 authored by M. Sanchez, Esq. appears in the book, "Managing Medical Devices within a Regulatory Framework" edited by Beth Ann Fiedler
Ms. Beth A. Fiedler
University of Central Florida
Read the Original
This page is a summary of: Healthcare Facility Users’ Legal Responsibilities and Risks, January 2017, Elsevier,
DOI: 10.1016/b978-0-12-804179-6.00013-7.
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