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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: Difference between revisions

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Medical Device Applications and
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Frequently Asked Questions
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Guidance for Industry and
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Frequently Asked Questions
-
Guidance for Industry and
Food and Drug Administration Staff
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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
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|reference=USA  Acceptance of Clinical Data to Support
Medical Device Applications and
Medical Device Applications and
Line 75: Line 37:
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== References ==
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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 -]] || MD || - || EN || […] “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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Latest revision as of 14:15, 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

References

 ScopeDocument partLanguagePreview
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 -MD-EN[…] “Clinical Investigation of Medical Devices for Human Subjects—Good Clinical Practice,” ISO 14155:2011, which FDA recognized in 2012 as a consensus…
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