Material, Impression

How Is ELW Classified?

Material, Impression is FDA product code ELW, Class 2, 21 CFR 872.3660.

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 9 clearances under this code; the FDA took a median of 126 days from receipt to decision on them.

What Do the Recalls Say?

The FDA has recorded 14 recalls under this product code since 2003. None was by a company in China. The root causes the FDA records most often are Packaging process control (3), Nonconforming Material/Component (1) and Process control (1).

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