The Food and Drug Administration (FDA) is announcing a public workshop to discuss scientific information bearing on whether hand-held Doppler ultrasound prenatal listening devices should be made available for use over-the-counter (OTC). This 1-day workshop is intended to provide members of the academic, scientific, and clinical communities; industry; consumer, and patient advocacy groups; and others with a forum for presenting their perspectives about available scientific literature and clinical studies relating to hand-held Doppler ultrasound prenatal listening devices. Written comments submitted to the docket before the workshop and information gathered at the workshop will be used by FDA to further identify and evaluate the risks and benefits associated with possible OTC availability of hand-held prenatal Doppler ultrasound listening devices.

Date and Time: The public workshop will be held on Wednesday, March 29, 2006, from 9 a.m. to 3:30 p.m. The deadline for registration is Friday, March 10, 2006. Requests to make presentations at the public workshop and written or electronic comments will be accepted until Friday, March 10, 2006.

Addresses: The public workshop will be held at the Hilton Washington DC North, 620 Perry Pkwy., Gaithersburg, MD, 20877. Additional information about and directions to the facility are available on the Internet here.


(FDA has verified the Web site address, but FDA is not responsible for any subsequent changes to the Web site after this document publishes in the Federal Register.) Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.

Submit electronic comments to:
http://www.fda.gov/dockets/ecomments.

Contact: Domini Cassis, Center for Devices and Radiological Health (HFZ-215), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, e-mail: domini.cassis@fda.hhs.gov, 240-276-2342.

Agenda: At the workshop, FDA will hear presentations and oral comments from interested members of the public regarding Doppler ultrasound technology as used in hand-held prenatal listening devices.

FDA anticipates that presenters may include representatives from the academic, scientific, and clinical communities; device, drug, and biological product manufacturers; consumer and patient advocacy groups; and others.

Registration and Requests for Presentations: There is no fee to attend this public workshop; however, registration is required. The deadline for registration is Friday, March 10, 2006. Early registration is recommended, as seats are limited. Space will be filled in order of receipt of registration. There will be no on-site registration. Please submit registration information (including name, title, firm name, address, e-mail address, telephone number, and fax number) by March 10, 2006 (see Contact). Interested persons who are unable to attend the workshop are encouraged to submit written comments (see Request for Comments).

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