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GUIDANCE DOCUMENT

Product Labeling for Certain Ultrasonic Surgical Aspirator Devices Guidance for Industry and Food and Drug Administration Staff October 2017

Final

This guidance is being distributed for comment purposes only.

Docket Number:
FDA-2016-D-3275
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

The Food and Drug Administration (FDA) is issuing this guidance to recommend the addition of a specific safety statement to the product labeling of certain ultrasonic surgical aspirator devices. Ultrasonic surgical aspirator devices are surgical tools intended to fragment, emulsify and aspirate hard and soft tissue. These devices can be used in many different surgical specialties for a wide range of procedures, including the debulking of malignant tumors. Ultrasonic surgical aspirators cause tissue fragmentation through the delivery of ultrasound energy to target tissue through an oscillating tip. Tissue fragments are aspirated through the inner lumen of the device. This mechanism of action creates the potential for tissue dissemination. The incorporation of suction/aspiration reduces but cannot eliminate this potential.

In light of the risk of tissue dissemination from use of these devices, the FDA is providing a specific labeling recommendation in this guidance to promote the safe and effective use of ultrasonic surgical aspirator devices.


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2016-D-3275.