Indicator, Physical/Chemical Sterilization Process

What Is FDA Product Code JOJ?

Indicator, Physical/Chemical Sterilization Process is FDA product code JOJ, Class 2, 21 CFR 880.2800.

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 4 clearances under this code; the FDA took a median of 212 days from receipt to decision on them.

What Do the Recalls Say?

The FDA has recorded 24 recalls under this product code since 2003. None was by a company in China. The root causes the FDA records most often are Labeling False and Misleading (4), Process control (3) and Nonconforming Material/Component (3).

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