View source for 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

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Medical Device Applications and
Submissions
Frequently Asked Questions 
-
Guidance for Industry and
Food and Drug Administration Staff  21-Feb-2018
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|DocScopes=MD
|DocName=Acceptance of Clinical Data to Support
Medical Device Applications and
Submissions
Frequently Asked Questions 
-
Guidance for Industry and
Food and Drug Administration Staff
|DocVersion=21-Feb-2018
|DocStatus=Current
|DocType=Official recommendation
|DocLanguage=EN
|DocDescription=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
|DocRestricted=No
|DocSubmittedBy=Florian Adragna
|DocContributors=
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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
|validity_area=USA
|scopes=MD
|doc_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=21-Feb-2018
|status=Current
|doc_type=Official recommendation
|language=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_link=https://www.fda.gov/regulatory-information/search-fda-guidance-documents/acceptance-clinical-data-support-medical-device-applications-and-submissions-frequently-asked
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<noinclude>
== References ==
{| class="wikitable" style="width:100%;"
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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). […]
|}
</noinclude>