Those who wish to make presentations during the public workshop should submit written notification including the following: (1) The specific issue(s) you intend to address; (2) the names and addresses of all individuals that will participate in your presentation; (3) the approximate amount of time your presentation will require; and (4) two copies of all presentation materials to Domini Cassis by March 10, 2006. Presentations will be limited to the topics outlined in the SUPPLEMENTARY INFORMATION section of this document and,depending on the number of speakers, FDA may limit the time allotted for each presentation. If you need special accommodations due to a disability, please contact Anne Marie Williams at 301-594-1283 at least 7 days in advance of the workshop.

Request for Comments: Interested persons may submit to the Division of Dockets Management (see Addresses) written or electronic comments regarding this document. Two paper copies of any mailed comments are to be submitted, except that individuals may submit one paper copy. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.


Transcripts: Following the workshop, transcripts will be available for review at the Division of Dockets Management (see Addresses).

SUPPLEMENTARY INFORMATION:

I. Background

Since July 2002, FDA has received three citizen petitions requesting that it grant OTC status to hand-held prenatal listening devices that produce no more than 20 mW/cm2 of Doppler ultrasound intensity (FDA Docket Nos. 2002P-0338, 2003P-0438, and 2004P-0329.) Currently, these products are class II devices that are legally available only by prescription. FDA denied petitions 2002P-0338 and 2003P-0438, citing its concern over the safety of exposing a developing fetus to Doppler ultrasound without the order or instruction of a physician, and referencing the following studies:

1. ``Sinistrality--A Side-Effect of Prenatal Sonography: A Comparative Study of Young Men.'' Keiler, H., et al.; Epidemiology; 12:618-623 (2001).
2. ``Acceleration of Fresh Fracture Repair Using the Sonic Accelerated Fracture Healing System (SAFHS): A Review.'' Warden, S.J., et al.; Calcified Tissue International; 66:157-163 (2000).
3. ``Acceleration of Tibial Fracture-Healing by Non-Invasive, Low Intensity Pulsed Ultrasound.'' Heckman, J., et al.; Journal of Bone and Joint Surgery; 76A:26-34 (1994).
4. ``Accelerated Healing of Distal Radial Fractures With the Use of Specific, Low-Intensity Ultrasound. A Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled Study.'' Kristiansen, T., et al.; Journal of Bone and Joint Surgery, 79A:961-973 (1997).

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