System, Thermal Regulating

What Is It?

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

What Is FDA Product Code DWJ?

System, Thermal Regulating is FDA product code DWJ, Class 2, 21 CFR 870.5900.

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

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. The review can be done by an FDA-accredited third party, which is usually faster. Chinese applicants hold 2 clearances under this code; the FDA took a median of 135 days from receipt to decision on them.

What Has Gone Wrong With It?

The FDA has recorded 70 recalls under this product code since 2004. None was by a company in China. The root causes the FDA records most often are Device Design (24), Nonconforming Material/Component (7) and Labeling False and Misleading (5).

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