FDAnews Device Daily Bulletin


Dec. 27, 2005

The FDA has scheduled a public workshop to discuss scientific matters related to whether hand-held Doppler ultrasound prenatal listening devices should be made available for over-the-counter (OTC) use.

The workshop, which will be held March 29, 2006 in Gaithersburg, Md., is expected to include presentations and comments from the academic, scientific and clinical communities; device, drug and biological product manufactures; and consumers and patient advocacy groups, the FDA said in a recent Federal Register notice.

The FDA will use information gathered at the workshop, and other comments, to evaluate the risks and benefits associated with possible OTC availability of the ultrasound listening devices. The products are now legally available only by prescription.

Since July 2002, the FDA has received three citizen petitions requesting it grant OTC status to hand-held prenatal listening devices that produce more than 20 mW/cm2 of Doppler ultrasound intensity. The FDA denied two petitions citing its concern over the safety of exposing a developing fetus to Doppler ultrasound without the order or instruction of a physician. The FDA reiterated its concerns in response to the most recent petition, but agreed to hold the workshop to discuss relevant issues surrounding the proposal for OTC sales, distribution, and unsupervised use of these devices.

This public workshop is not intended to address legal or regulatory issues, the FDA said. The deadline for registering is March 10, 2006. To view the workshop notice, access http://www.fda.gov/OHRMS/DOCKETS/98fr/04p-0329-nm00001.pdf (http://www.fda.gov/OHRMS/DOCKETS/98fr/04p-0329-nm00001.pdf).