TABLE 6-5 Device Classification and Application Requirements for FDA Review

Device Class Product Examples Level of Control Exempt/ Substantially Equivalent*Type of Application
Class I Low risk Crutches, Band-aids®, tongue depressors General controls Exempt None
Without exemption 510(k)
Class II Medium risk Syringes, wheelchairs, CAD General and special controls Exempt None
Without exemption 510(k)
Class III High risk Mammography devices, pacemakers, breast implants General controls with premarket approval New device Premarket approval
Substantially equivalent to device already approved before 1976**510(k)
*

Class I/II devices are exempt from the 510(k) application process if they have not been significantly modified or changed since before the passage of the medical device amendments in 1976 or they are specifically exempted by FDA regulations. For Class III devices, a 510(k), instead of a premarket approval, can be used to show substantial equivalence in safety and efficacy to a predicate device, having the same intended use and technological characteristics.

**

For all Class III devices a premarket approval application is required unless the device was on the market prior to the passage of the medical device amendments in 1976, or substantially equivalent to such a device. The 510(k) application will be required for “substantially equivalent” Class III devices.

From: 6, The Necessary Environment for Research and Development

Cover of Saving Women's Lives
Saving Women's Lives: Strategies for Improving Breast Cancer Detection and Diagnosis.
Institute of Medicine (US) and National Research Council (US) Committee on New Approaches to Early Detection and Diagnosis of Breast Cancer; Joy JE, Penhoet EE, Petitti DB, editors.
Washington (DC): National Academies Press (US); 2005.
Copyright © 2005, National Academy of Sciences.

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