Burn Kit Without Drug

What Is It?

This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

What Is FDA Product Code OJJ?

Burn Kit Without Drug is FDA product code OJJ, Class 1, 21 CFR 878.4022.

How Does It Reach the US Market?

The FDA exercises enforcement discretion for this code and does not currently require a premarket submission for devices that meet the conditions it has set for it.

What Has Gone Wrong With It?

The FDA has recorded 7 recalls under this product code since 2017. None was by a company in China. The root causes the FDA records most often are Process control (1), Nonconforming Material/Component (1) and Device Design (1).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.