With the continuous expansion of new pneumonia in the United States, the U.S. government has had to make an urgent decision to exempt 27 U.S. enterprises from tariffs on more than 100 medical related products imported from China, such as masks. The exempted products are mainly masks, disposable medical gloves, sterilized wet paper towels, sample collection utensils and other medical supplies in short supply. The United States mainly relies on imports in this regard.

The export of medical masks to the United States needs to apply for FDA. According to FDA classification, masks are divided into sterile and non sterile categories.

The FDA registration process is as follows:

1. Duns code and FDA account application (2 weeks), if you apply for small business audit fees will be reduced.

2. If you want to apply for small business audit fee relief, Download form3602a to the tax authority, fill in and stamp it and mail it to FDA, and reply within 60 days.

3. Audit fee payment, the latest audit fee in 2020 is about $11594, and the small enterprise relief needs $2899.

4. 510k document preparation

5. Through the product code, regulation number and other standards and regulations applicable to the product interpretation: ISO10993, ASTM, iso11135 and FDA series guidance: biocompatibility, sterility and performance testing. Establish performance test report, biocompatibility evaluation, sterility verification document, packaging and transportation verification and shelf life verification document.

6. Prepare a complete set of 510k documents according to the 510k checklist. Download 510kecopy verification software and submit it after confirming that the file format is correct.

7. 510k documents are submitted to CDRH through ecopy for 60 days or so. Get 510k certificate or ask for supplement. If additional documents are required, they shall be completed within 180 days and submitted by ecopy.

8. The mdufa system is registered. Only after the enterprise product is registered, the status of 510k is active. The registration fee in 2020 is $5236 per product.

Note: if the product is sold to the U.S. market, be sure to prepare for the review of the cfr820 system.