FDA Issues New Classification on Male Vibrator

The FDA issued new rules in the Federal Register on male vibrators for premature ejaculation, classifying the devices as Class II with special controls. The move comes after British devicemaker Ergon Medical won de novo approval for its Prolong device May 20, which then prompted the FDA to draw up rules on future, comparable devices.

The type of vibrator in question is designed to increase the period of time between arousal and ejaculation using vibrating stimulation therapy, the document says.

The FDA has concluded these kinds of device’s potential risks as pain or discomfort from misuse, burns, electrical shock, adverse skin reactions, patient injury caused by device breakage or failure, and interference with other electrical devices/electrical equipment.

To mitigate these risks, the FDA advises labeling must include specific instructions regarding proper device placement and use, the portions of the device that contact the patient must be biocompatible, analysis/testing must demonstrate electromagnetic compatibility safety, electrical safety and thermal safety, and mechanical safety testing must show that the device can withstand forces encountered during use.

Going forward, the FDA does not exempt these devices from premarket 510(k) notification on the part of devicemakers. — Jason Scott