Classification of Low Energy Ultrasound Wound Cleaner and Issuance of Related Guidance

FDA recently classified the Low Energy Ultrasound Wound Cleaner as a Class II device and issued a guidance document for such devices. This classification and the subsequent guidance document are in response to a petition filed by Celleration, Inc. in April 2004 for their Celleration MIST Therapy System TM. Celleration’s device was the first of its kind and hence had to go through the 513(f)(1), 513(f)(2) classification route.

The guidance is effective immediately. However, FDA will accept any comments that it receives in regards to this guidance to consider if any amendments to the document are required.

The Guidance is available on the internet at CDRH’s website and can also be obtained by fax. For more details on the Classification or on the guidance document, please refer to the following Federal Register announcements –

http://www.fda.gov/OHRMS/DOCKETS/98fr/05-22068.pdf and

http://www.fda.gov/OHRMS/DOCKETS/98fr/05-22069.pdf

If any questions on the report or comments please email us at info@mdiconsultants.com.

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