Zdrowie i gospodarka · 07/02/2002

Orthopedic Devices; Proposed Classification for the Resorbable Calcium Salt Bone Void Filler Device

The Food and Drug Administration (FDA) is proposing to classify the resorbable calcium salt bone void filler device intended to fill bony voids or gaps, caused by trauma or surgery, that are not intrinsic to the stability of the bony structure into class II (special controls). The agency is also publishing the recommendation of the Orthopedic and Rehabilitation Devices Panel (the Panel) regarding the classification of this device. After considering public comments on the proposed classification, FDA will publish a final regulation classifying this device. This action is being taken to establish sufficient regulatory controls that will provide reasonable assurance of the safety and effectiveness of this device. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of a draft guidance document that the agency proposes to use as a special control for the device.