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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.

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