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The Medical Device Developer's Guide to IEC 60601-1

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FDA Requirements for Medical Devices

This page briefly mentions some of the basic concepts involved in FDA regulation for medical devices, together with links to relevant pages on the FDA website. Full details are presented by the FDA on their Device Advice site.

Class I devices are defined as non-life sustaining. These products are the least complicated and their failure poses little risk.

Class II devices are more complicated and present more risk than Class I, though are also non-life sustaining. They are also subject to any specific performance standards.

Class III devices sustain or support life, so that their failure is life threatening.

The FDA gives advice on how to determine the classification of a specific medical device.

Before a medical device can be marketed in the USA a marketing application must be submitted to the FDA and clearance obtained.

Most Class I devices and a few Class II devices are exempt from the requirement for submission of a marketing application. However, these devices are not exempt from other general controls. All medical devices must be manufactured under a quality assurance program, be suitable for the intended use, be adequately packaged and properly labeled, and have establishment registration and device listing forms on file with the FDA.

A few Class I devices are additionally exempt from the GMP requirements, with the exception of complaint files and general record keeping requirements.

The FDA has a list of exempted devices.

A 510(k) is a premarketing submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent (SE), to a legally marketed device that is not subject to premarket approval (PMA).

The FDA site describes the 510(k) or premarket notification in detail.

Premarket Approval (PMA) is the most stringent type of device marketing application required by FDA. A PMA is an application submitted to FDA to request clearance to market, or to continue marketing of a Class III medical device.

The FDA describes the Premarket Approval (PMA) in detail.

An investigational device exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to FDA. All aspects of the IDE process are described by the FDA.

The current Good Manufacturing Practice (GMP) requirements set forth in the Quality System (QS) regulation require that domestic or foreign manufacturers have a quality system for the design, manufacture, packaging, labeling, storage, installation, and servicing of finished medical devices intended for commercial distribution in the United States.

The FDA describes the quality system requirements in detail.



Medical Devices Regulations

Technical File



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The author thanks the International Electrotechnical Commission (IEC) for permission to use material from the IEC 60601-1 international standard .

All extracts are copyright © IEC, Geneva, Switzerland. All rights reserved. Further information on the IEC, its publications and its role is available from IEC takes no responsibility for and will not assume liability for damages resulting from the reader's misinterpretation of the referenced material referenced due to its placement and context in this publication. The material is reproduced or rewritten with their permission.