View source for Reference:USA Acceptance of Clinical Data to Support Medical Device Applications and Submissions Frequently Asked Questions - Guidance for Industry and Food and Drug Administration Staff 21-Feb-2018 -

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|RefScope=MD
|RefDocPart=-
|RefLanguage=EN
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{{:Document:USA Acceptance of Clinical Data to Support Medical Device Applications and Submissions Frequently Asked Questions - Guidance for Industry and Food and Drug Administration Staff 21-Feb-2018}}

{| class="wikitable gplx-infobox"
|-
! colspan="2" class="gplx-infobox-header" | Reference Details
|-
! Module
| Module 1 — Unit 1.3.0
|-
! Scope
| MD
|-
! Document part
| -
|-
! Language
| EN
|-
! Original entry by
| Florian Adragna
|-
! Contributors
| 
|-
! Tags
| [[Glossary:TAG-00043-Goo-tek|Good clinical practice]], [[Glossary:TAG-00201-Cli-eSt|Clinical investigation]], [[Glossary:TAG-00155-Med-Med|Medical device]], [[Glossary:TAG-00320-Foo-eri|FDA]]
|-
! Comment
| GCP for medical device clinical investigations (ISO 14155)
|}

== Content ==
[…]
“Clinical Investigation of Medical Devices for Human Subjects—Good Clinical Practice,” ISO 14155:2011, which FDA recognized in 2012 as a consensus standard).
[…]