Popular

Check out our most popular posts and documents below or search our site for any keyword.  Many are particularly relevant to the development of medical device, medical mobile app, and digital health software.  Also find links for other helpful organizations and tools!

Most Popular!
Helpful Organizations
Tools
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2016-02 Applying Human Factors and Usability Engineering to Medical Devices-Draft Guidance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