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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 -: Difference between revisions

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

Latest revision as of 13:49, 16 July 2026



Document information
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

Validity area USA
Scope(s) MD
Document name Acceptance of Clinical Data to Support

Medical Device Applications and Submissions Frequently Asked Questions - Guidance for Industry and Food and Drug Administration Staff

Version / Revision 21-Feb-2018
Status Current
Document type Official recommendation
Language(s) EN
Description GUIDANCE DOCUMENT

Acceptance of Clinical Data to Support Medical Device Applications and Submissions: Frequently Asked Questions Guidance for Industry and Food and Drug Administration Staff February 2018 Final

Docket Number: FDA-2013-N-0080 Issued by: Center for Biologics Evaluation and Research Center for Devices and Radiological Health

Official source Official link
Restricted access No
Submitted by Florian Adragna
Contributors


Reference Details
Module Module 1 — Unit 1.3.0
Scope MD
Document part -
Language EN
Original entry by Florian Adragna
Contributors
Tags Good clinical practice, Clinical investigation, Medical device, FDA

Content

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

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