Most Popular Documents Newsletter

Changes To Medical Software Policies from 21st Century Cures Act Draft Guidance Dec 2017 

FDA Commissioner Digital Health Software Policy Statement December 2017 

Medical Device Innovations Section of 21st Century Cures Act 

FDA Software As a Medical Device (SAMD) Clinical Evaluation Final Guidance 

FDA Final Postmarket Cybersecurity Guidance

FDA Final Premarket Cybersecurity Guidance

FDA Final Mobile Apps Guidance

FDA Medical Device Data System Classification Rule

FDA CyberSecurity for Networked Medical Devices Containing Off-the-shelf Software Guidance

FDA General Principles of Software Validation (GPSV) Guidance

Preamble to Final FDA GPSV Guidance

21 CFR Part 11 SoftwareCPR Memory Jogger

 21 CFR Part 11 Electronic Records;Electronic Signatures Rule

21 CFR Part 11 Feb 2003 Federal Register Notice Announcing Major Redirection for Part 11

 21 CFR Part 11 Final Scope and Application Guidance 09/03/03

FDA IOM 2007  Electronic Records and Computerized Complaint Data

FDA Guidance Computerized Systems Used in Clinical Trials

FDA Software Submission Guidance  

FDA Off-the-shelf Software Submission Guidance

FDA Blood Bank Submission Guidance

FDA Food Processing Computer System Guidance

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Links to Selected Software Tools

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