Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices

This ICR collects information from reprocessors of single-use devices (SUDs). If the original SUD or an attachment to it prominently and conspicuously bears the name of the manufacturer, then the reprocessor of the SUD is required to identify itself by name, abbreviation, or symbol, in a prominent and conspicuous manner on the device or attachment to the device. Information concerning the identification of the name of a reprocessor of single-use devices is necessary so that users do not misattribute adverse events associated with a reprocessed device to the original manufacturer. When reporting adverse events involving the use of reprocessed single-use devices, health care providers may mistakenly believe that the reprocessed device is a new product from the original manufacturer of the device and not from the reprocessor. The information and records generated under this labeling requirement will be used so that physicians, hospital staff, and patients can associate a particular device with a particular manufacturer. This is especially important in the event of a recall, warning, patient injury, or product malfunction.

The latest form for Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices expires 2021-06-30 and can be found here.

Establishments listing less than 10 SUDs

Federal Enterprise Architecture: Health - Public Health Monitoring