Bioelectronics Corp (BIEL)

[kidnova]

The amateur nature of BIEL's management is on full display in the Executive Summary of Tuesday's meeting. Their arguments have been summarily dismissed.

Submission from BioElectronics Corporation
The request seeking a change in classification from Class III to II from BioElectronics Corporation propose that all SWD devices are thermal. They are proposing that their devices should be available with an over-the-counter (OTC) designation. Currently, thermal SWD devices are regulated as Class II devices, and have only been cleared for prescription use (product code: IMJ). BioElectronics is specifically interested in the OTC change as well as a change in classification to Class II for their devices for the indications of treatment of “relief of menstrual pain and discomfort and relief of musculoskeletal pain.”

The purpose of this meeting is not to determine what qualifies as thermal or nonthermal SWD, nor to recommend whether the existing prescription use devices can appropriately be used as OTC devices. OTC use of nonthermal SWD or thermal SWD has not been classified by FDA. These discussions are not applicable to the overall classification of the SWD device. Furthermore, the indications for use included within this request are outside the currently cleared indications for use; hence, they are beyond the scope of this classification proceeding.

http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/OrthopaedicandRehabilitationDevicesPanel/UCM352560.pdf