Charting our course for 2018-2020

Since 2012, we at the Center for Devices and Radiological Health have set as our North Star the vision of patients in the U.S. having access to high-quality, safe, and effective medical devices of public health importance first in the world. [...]FDA will be able to conduct a post-approval inspectio...

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Bibliographic Details
Published inHealthcare Innovation
Main Author Shuren, Jeff
Format Trade Publication Article
LanguageEnglish
Published Newton Endeavor Business Media 09.03.2018
Subjects
Collaboration
Decision making
Employees
Innovations
Medical equipment
United States > US
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Summary:Since 2012, we at the Center for Devices and Radiological Health have set as our North Star the vision of patients in the U.S. having access to high-quality, safe, and effective medical devices of public health importance first in the world. [...]FDA will be able to conduct a post-approval inspection rather than a pre-approval inspection where appropriate. By applying these three approaches more systematically we believe we will arrive at the threshold of achieving our vision in the next three years. [...]as a measure of success, we aim to have more than 50 percent of manufacturers of novel technologies for the U.S. market intend to bring their devices to the U.S. first or in parallel with other major markets by December 31, 2020.