USA Regulatory Framework Medical Device registration

USA Medical devices regulation basics

Here below are reported some of the most relevant guidance for Medical Device Registration in USA market:

Major Regulations

Regulation	Year
Establishment Registration & Device Listing For Manufacturers & Importers Of Devices	2010
Food, Drug and Cosmetic Act – Medical Devices	2014
Labeling	2012
Medical Device Reporting	2010
Medical Device Tracking Requirements	2011
Medical Devices; Reports Of Corrections And Removals	2010
Quality Systems Regulations (QSR)	2016

General Guidance Documents

Document	Year
Bar Code Label Requirements – Question and Answer	2011
Certifications To Accompany Device Applications/Submissions	2009
Computerized Systems Used in Clinical Trials	2007
Design Control Guidance for Medical Device Manufacturers	1997
Emergency Use Authorization of Medical Products	2007
Expedited Review for Medical Device Submissions	2008
FDA Export Certificates	2005
Good Reprint Practices – Distribution of Medical Journal Articles for Cleared Medical Devices	2009
ICH Q9 Quality Risk Management	2006
Labeling for Medical Devices	2001
Post Market Surveillance Guidance	2006
Premarketing Risk Assessment	2005
Providing Regulatory Submissions in Electronic Format – Content of Labeling	2005

Specific Guidance Documents

Document	Year
Container and Closure System Integrity Testing in Lieu of Sterility Testing	2008
Content of Premarket Submissions for Software Contained in Medical Devices	2005
Current Good Manufacturing Practice for Combination Products	2004
Expedited Access for Premarket Approval Medical Devices	2014
General Principles of Software Validation	2002
Global Unique Device Identification Database – Guidance for Industry	2014
In Vitro Diagnostic (IVD) Device Studies FAQ	2007
Mobile Medical Applications Guidance for Industry	2015
Premarket Assessment of Pediatric Medical Devices	2004
Unique Device Identification System – FDA Final Rule	2013
Use of Symbols on Labels of IVDs for Professional Use	2004
Validation Data for Reprocessed Single-Use Devices	2006

Additional Information

Document	Year
Human Factors in Medical Device Design	2011
Small Business Guide to FDA	2011
US FDA Transparency Initiative: Improving Transparency To Regulated Industry Phase III Report	2011

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