Released	Title
2018-12	Quick link to US FDA 21CFR820
2017-12	FDA Software As a Medical Device (SAMD) Clinical Evaluation Final Guidance
2017-12	Changes to Medical Software Policies Resulting from the 21st Century Cures Act
2016-12	Postmarket Management of Cybersecurity in Medical Devices
2016-02	Applying Human Factors and Usability Engineering to Medical Devices-Draft Guidance
2016-01	Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices
2014-12	Infusion Pumps Total Product Life Cycle
2014-11	Design Considerations for Devices Intended for Home Use
2014-10	Content of Premarket Submissions for Management of Cybersecurity in Medical Devices
2013-09	FDA Final Mobile Apps Guidance
2013-08	Radio Frequency Wireless Technology in Medical Devices
2011-04	76 FR 8637 – Medical Devices; Medical Device Data Systems
2009-08	2009-08-Class II Special Controls Guidance Document- Antimicrobial Susceptibility Test (AST) Systems
2007	FDA IOM 2007 Electronic Records and Computerized Complaint Data
2007-05	FDA Guidance Computerized Systems Used in Clinical Trials
2005-01	FDA CyberSecurity for Networked Medical Devices Containing Off-the-shelf Software Guidance
2002-01	General Principles of Software Validation-Final Guidance Preamble to Final FDA GPSV Guidance
1999-09	FDA Off-the-shelf Software Submission Guidance
1997-01	FDA Blood Bank Submission Guidance
Late 90’s	FDA Food Processing Computer System Guidance
1997-03	21 CFR Part 11 Electronic Records; Electronic Signatures Rule
1983-02	Computerized Systems in Drug Establishments

Organizations that may provide helpful information for product and design quality assurance.

FDA Home Page	AAMI’s Home Page
MDMA’s Home Page	Parenteral Drug Association Home Page

Tools that may help maintain quality records.

Ranorex Automated Test Tools

GessNet Medical Device Risk Management & Safety Assurance Case Tool

RMTrak Trace tool for tagging, tracing, allocating, and verifying requirements

Encompass Medical Device Translation Services and Content Automation Solutions

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