New PMA (Pre-market Approval) requirement for three devices
This article was originally published in Clinica
Executive Summary
Manufacturers of three medical devices have been put on alert that they must soon file a premarket approval application with the FDA if they want to continue marketing their products. The products are: indwelling blood oxyhaemoglobin concentration analysers, a photo electric device used to measure the oxygen carrying capacity of haemoglobin in blood; cardiopulmonary bypass pulsatile flow generators, an electrically and pneumatically-operated device placed in a cardiopulmonary bypass circuit to create pulsatile blood flow; and the ocular plethysmograph, a device that diagnoses occluded carotid arteries by measuring whether pulsations of the artery produce volume changes in the eye.