The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Product Labeling for Certain Ultrasonic Surgical Aspirator Devices.'' FDA is providing a specific labeling recommendation in this guidance to promote the safe and effective use of ultrasonic surgical aspirator devices. The labeling recommendation is being made in light of the risk of tissue dissemination and relates to use of these devices in the removal of uterine fibroid. This draft guidance is not final nor is it in effect at this time.
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Product Labeling for Certain Ultrasonic Surgical Aspirator Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Product Labeling for Certain Ultrasonic Surgical Aspirator Devic...
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81 FR 79028
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“Product Labeling for Certain Ultrasonic Surgical Aspirator Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability,” thefederalregister.org (November 10, 2016), https://thefederalregister.org/documents/2016-27106/product-labeling-for-certain-ultrasonic-surgical-aspirator-devices-draft-guidance-for-industry-and-food-and-drug-adminis.