BOX 1-1

IOM Study on the Public Health Effectiveness of the FDA 510(k) Clearance Process

The IOM Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process will assess whether the 510(k) clearance process sufficiently protects patients and promotes public health. Specifically, the IOM committee will answer two principal questions:

  • Does the current 510(k) process optimally protect patients and promote innovation in support of public health?

  • If not, what legislative, regulatory, or administrative changes are recommended to optimally achieve the goals of the 510(k) process?

A final consensus report is expected to be released in the middle of 2011.

BOX 1-2

Definitions of Medical Device Classes

  • Class I devices are subject to the least regulatory control. They present minimal potential for harm to the user and are often simpler in design than Class II or Class III devices.

  • Class II devices are those for which general controls alone are insufficient to ensure safety and effectiveness and for which existing methods are available to provide such assurances.

  • Class III devices are those for which insufficient information exists to ensure safety and effectiveness solely through general or special controls. Class III devices are usually those which support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury.

SOURCE: FDA, 2000.

explicitly part of the 510(k) process, they are related to FDA’s ability to identify safety concerns about medical devices throughout their life cycle.

The first workshop was held on June 14–15, 2010, in Washington, DC. At that workshop, information was presented to the committee regarding the legislative history of the Medical Device Amendments of 1976, which



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