Pulse Oximeters to be Considered For Over-The-Counter Use
Apr 28, 2005 - 10:37:00 AM
In addition to exploring the OTC issue, FDA hopes to generate discussion on techniques for validating pulse oximeters for neonatal use. Currently, the devices are tested on adults and calculations for neonates are then derived from that data. FDA is interested in hearing from the panel regarding possible alternate testing approaches.
By FDA Advisory Committe, [RxPG] FDA will solicit feedback from its Anesthesiology & Respiratory Therapy Devices Panel on over-the-counter sale of pulse oximeters.
To date, no pulse oximeters have been approved for OTC use; however, the agency is seeing a trend toward applications seeking that status.
The meeting is largely dedicated to discussing general issues associated with pulse oximeters. No product applications for specific devices will be reviewed.
In addition to exploring the OTC issue, FDA hopes to generate discussion on techniques for validating pulse oximeters for neonatal use. Currently, the devices are tested on adults and calculations for neonates are then derived from that data. FDA is interested in hearing from the panel regarding possible alternate testing approaches.
A third issue FDA plans to raise during the panel meeting relates to potential differences between reflectance sensor and transmissive sensor technology.
Reflectance sensors, which are less commonly used, are designed with the light emitter and detector on the same side of the device. Transmissive sensors have the emitter and detector on opposite sides and light travels through tissue to the detector.
There may be some applications where one design works better than the other, according to FDA. The agency is seeking comments from the panel on whether the two designs are essentially equivalent or whether in certain instances one design type may outperform the other.
At the meeting, FDA also will present on the agencys Critical Path Initiative and CDRH Office of Surveillance & Biometrics responsibilities for postmarket study design. Earlier this year, the device center shifted responsibility for design and follow-up of condition-of-approval studies from the Office of Device Evaluation to OSB. It has been informing panels about the shift.
