Reminder, Medication

What Is It?

A medication reminder is a device intended for medical purposes to provide alerts to patients or healthcare providers for pre-determined medication dosing schedules. The device may incorporate wireless communication.

What Is FDA Product Code NXQ?

Reminder, Medication is FDA product code NXQ, Class 1, 21 CFR 890.5050.

What Does It Take to Sell It in the United States?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States. It is also exempt from most of the quality system regulation.

What Has Gone Wrong With It?

The FDA has recorded 1 recall under this product code since 2006. None was by a company in China. A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.