by
Barbara Kram, Editor | February 27, 2006
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
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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 Filed12-21-05; 8:45 am]
BILLING CODE 4160-01-S
[Federal Register: December 22, 2005 (Volume 70, Number 245)][Notices][Page 76060-76061]From the Federal Register Online via GPO Access [wais.access.gpo.gov][DOCID:fr22de05-63]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004P-0329]
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