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

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

	Scope	Document part	Language	Preview
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…