[Federal Register: December 22, 2005 (Volume 70, Number 245)]
[Page 76060-76061]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2004P-0329]

Hand-Held, Doppler Ultrasound Prenatal Listening Devices

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice of public workshop; request for comments.


     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 at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.hilton.com/en/hi/hotels/index.jhtml?ctyhocn=GAIGHHF.
 (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.

[[Page 76061]]

Submit electronic comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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 
    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).


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).
    5. ``Routine Ultrasound Screening in Pregnancy and the Children's 
Subsequent Handedness.'' Kieler, H., et al.; Early Human Development; 
50:233-245 (1998).
    FDA reiterated its concerns in response to the most recent 
petition, 2004P-0329, but agreed to hold a public workshop in which 
relevant issues surrounding the proposal for OTC sales, distribution, 
and unsupervised use of these devices could be discussed. This public 
workshop is not intended to address legal or regulatory issues. Rather, 
FDA intends to collect information from outside experts and 
stakeholders that could help the agency better identify and evaluate 
the risks and benefits of uncontrolled exposure to Doppler ultrasound 
energy introduced through hand-held prenatal listening devices.

II. References

    The above references have been placed on display in the Division of 
Dockets Management (see Addresses) and may be seen by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: December 16, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E5-7643 Filed 12-21-05; 8:45 am]