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

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

Bar Code Label Requirements – Question and Answer2011
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

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

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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