FDA adds to SUDs (single-use devices) 510(k) list
This article was originally published in Clinica
Executive Summary
The US FDA has added another four products to its list of single-use devices (SUDs) requiring premarket review before they can be cleaned, disinfected and sterilised by a third-party reprocessor. The products are: orthodontic metal brackets, tracheobronchial suction catheters, and both flexible and basket ureteral stone dislodgers.