Overview of the US FDA medical device approval process.


Journal Article (Review)

Increasing barriers to medical device innovation in the United States including constrained financial resources and rising research costs require that physicians take on greater involvement in medical device development, evaluation, and regulatory processes. Such involvement requires that physicians understand basic aspects of the regulatory process for medical devices and recognize the myriad opportunities for involvement in these activities.

Full Text

Cited Authors

  • Sastry, A

Published Date

  • January 2014

Published In

Volume / Issue

  • 16 / 6

Start / End Page

  • 494 -

PubMed ID

  • 24880920

Pubmed Central ID

  • 24880920

Electronic International Standard Serial Number (EISSN)

  • 1534-3170

International Standard Serial Number (ISSN)

  • 1523-3782

Digital Object Identifier (DOI)

  • 10.1007/s11886-014-0494-3


  • eng