Inclusion of patient-reported outcome instruments in US FDA medical device marketing authorizations
Abstract Background The U.S. Food and Drug Administration encourages the incorporation of the patient voice throughout the medical device total product lifecycle. This study examined the incorporation of patient-reported outcome (PRO) instruments in the evaluation of medical devices over a six-year...
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| Main Authors: | , , , , , |
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| Format: | Book |
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SpringerOpen,
2022-04-01T00:00:00Z.
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| Subjects: | |
| Online Access: | Connect to this object online. |
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Internet
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| Call Number: |
A1234.567 |
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| Copy 1 | Available |