FDA Registration process for Steam Eye Mask

Steam eye mask is a self-heating temperature control technology, so that the moisture in the air and iron powder in the eye mask chemical reaction, the formation of hot body, generating the naked eye can not see the fine warm steam. It is in response to the needs of the eye care market to develop a class of generic name products, because of its ability to spontaneously form heat, steam named.

Steam eye mask belongs to the United States FDA under the jurisdiction of the medical device class products, exported to the United States for FDA registration. For medical device registration with FDA, it is required to pay the US FDA fee, which is USD5672 per year in 2022

Process for FDA Registration of Steam Eye Mask

1. Fill in the FDA registration application form;

2. Submit registration materials of neck support;

3. Pass the examination and obtain the FDA registration number of the neck support.