Intertech Engineering Associates, Inc.

Library

Regulatory and technical resources of general interest to the medical device community are available here.

We mirror a subset of the FDA regulations and guidance documents here. This subset is of general interest to those companies producing medical devices with embedded software, and/or those who use software in the manufacture of medical devices.

From time to time, Intertech employees' articles are regularly selected for publication in industry periodicals on topics of interest to the industry. Click here to view and read a collection of our article reprints.

Webinars are occasionally offered at no cost to the industry. Click here to access archived webinars on various topics related to regulatory issues and medical device software.

FDA Regulations, Rulings 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.

A guidance for Mobile Medical Applications was released by the FDA on February 9, 2015. This guidance clarifies which apps are considered to be medical devices, which app developers are considered to be device manufacturers, and what regulations apply.

A draft guidance for Investigational Device Exemptions (IDE) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies was released by the FDA on November 14, 2011.

The Regulation for Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices was released by the FDA on February 9, 2015.  

(MDDS's) was released by the FDA on February 14, 2011. It specifies certain specific MDDS's that will now be considered Class I devices. This will not relieve manufacturers from any QSR Design Control requirements.

The Guidance for Industry and FDA Staff - Infusion Pumps Total Product Life Cycle - issued on Dec 2, 2014.  Even non-infusion pump manufacturers will benefit from reading this to get a sense of where the FDA is headed with PMN guidance.

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 Cyber Security 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.

The Reminder from FDA: Cyber Security for Networked Medica Devices is a Shared Responsibility memo is a reminder of the contents ofthe Cyber Security Guidance of 2005, and some clarification of misunderstandings of which the FDA is aware.

The Off-The-Shelf Software Use in Medical Devices (1999) provides guidance on how to decide what to do with OTS software used as part of medical devices. Validation and regulatory submission considerations are discussed.

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 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.

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