Medical Device Amendments

[AI summary unavailable — showing source text] Medical Device Amendments - Provides for the classification of medical devices intended for human use based upon their safety and effectiveness. Describes such classification as follows: (1) Class I includes devices not purported to be for a use which is of substantial importance in supporting, sustaining, or preventing impairment of human life or health and do not present a potential unreasonable risk of illness or injury, and for which general controls, as defined are sufficient; (2) Class II includes devices for which it is necessary to establish a performance standard to provide reasonable assurance of their safety and effectiveness; and (3) Class III includes devices for which there is insufficient information for the establishment of a performance standard to provide reasonable assurance of their safety and effectiveness, are purported to be for a use which is of substantial importance in supporting, sustaining, or preventing impairment of human life or health, or present a potential unreasonable risk of illness or injury. Gives the Secretary of Health, Education, and Welfare responsibility for classifying all such devices. Authorizes the Secretary to establish panels of expe…