FDA Regulations and Guidance Documents

We've made copies of some of the FDA documents that are key to our interests available here for our clients, prospects, workshop attendees and other friends. You can browse these here by clicking on the titles. You can also make a local copy on your own computer if you like. All are Acrobat (.pdf) files.

This is by no means a comprehensive list of all FDA guidance documents. Visit the FDA-CDRH website for the complete collection. If you have a suggestion for what other FDA publications we could provide here, please let us know at librarian@intertechengineering.com.

The General Principles of Software Validation (PDF-161KB) is the MUST READ document for anyone developing or validating software for medical devices or used to automate any part of a medical device production or quality system.

The Guidance for Content of Premarket Submissions for Software Contained in Medical Devices (PDF-162KB) defines "level of concern" for software embedded in medical devices and sets out the agency expectations for premarket submissions for devices containing software based on level of concern.

The Cybersecurity Guidance (PDF-181KB) deals specifically with network connected devices and how to trade-off defending the systems from outside attack, and the validation responsibilities of the manufacturer and user.

Quality System Regulations - 21 CFR 820 (PDF-277KB) is the set of regulations that comprise what is referred to as the Quality System Regulations (QSRs). These are the regulations that are further explained by the above guidances.  Subpart C (820.30, pg 57) of this document is what is referred to as the Design Control Regulations.  Note that the regulation doesn't start until page 54.  The first 53 pages are the preamble and are interesting reading too.

Design Control Guidance for Medical Device Manufacturers (PDF-146KB) explains the FDA's interpretation of what the Design Control Regulations (21 CFR 820.30) mean.  Here's where you go to understand the important terms design inputs, design outputs, design reviews, design verification, design validation, design transfer, design changes and design history file.

Part 11 - 21 CFR Part 11 (PDF-216KB) is the set of regulations related to electronic records and electronic signatures that is better known as Part 11.

The Part 11 Guidance (PDF-253KB) addresses compliance with the Part 11 regulations on electronic records and electronic signatures.

The Quality System Inspection Technique (PDF-949KB) guide is the training manual FDA inspectors use. This is valuable for industry to help understand the expectations of the inspectors when performing quality system inspections.