Medical device development : regulation and law

Medical device development : regulation and law /

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Bibliographic Details
Main Authors: Kahan, Jonathan S. (Author), Heyl, Michael S. (Author)
Format: Book
Language:English
Published: [Needham, Massachusetts] : Barnett International, 2020
Edition:[Fourth edition].
Subjects:
Medical instruments and apparatus > Law and legislation > United States.
Medical instruments and apparatus > Safety regulations > United States.
Medical instruments and apparatus > Design and construction.
Medical Device Legislation.
Equipment Design > legislation & jurisprudence.
Equipment and Supplies > legislation & jurisprudence.
Equipment Safety > legislation & jurisprudence.
United States.
Table of Contents:
  • The framework for regulation of medical devices
  • The 510(k) premarket notification process
  • Device modifications requiring a 510(k) notice
  • FDA regulation of medical device software and digital health technology
  • The investigational device exemption application : overview of the IDE process and humanitarian devices
  • Medical device clinical studies
  • The premarket approval application
  • Review of a premarket approval application
  • PMA supplements
  • Medical device reclassification
  • The regulation of in vitro diagnostics
  • The quality system regulation
  • Compliance
  • Medical device exports and imports
  • Product jurisdiction and the regulation of combination products
  • Working well with FDA.

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