Cardiovascular Devices; Notice of Agency Decision Not To Enforce Requirement of Premarket Approval; Replacement Heart Valve Allografts

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The Food and Drug Administration (FDA) is announcing that it will no longer enforce the premarket approval requirement for replacement heart valve allografts. Upon publication of this document, these devices may be commercially distributed without an approved premarket approval application (PMA) and without an approved investigational device exemption (IDE). The agency intends to initiate procedures for the purpose of placing these devices into class II. FDA is taking this action because it believes that special controls may be more appropriate than premarket approval to ensure the safety and effectiveness of heart valve allografts. This document also confirms that heart valve allografts, and the processors and distributors of these devices, are still subject to the general controls applicable to all medical devices.