With the continuous expansion of new pneumonia in the United States, the US government has had to urgently make a decision to exempt tariffs on more than 100 medical related products imported from China by 27 US companies, such as masks. The exempted goods mainly include masks, disposable medical gloves, disinfected wet tissues, sample collection containers and other scarce medical supplies, and the United States mainly relies on imports in this regard. Medical masks exported to the United States require an FDA application. According to FDA classification, masks are pided into two categories: sterile and non sterile. The FDA registration process is as follows: 1. DUNS code and FDA account application (2 weeks). If applying for small business review fees, there will be a reduction. 2. If applying for fee reduction for small business review, download Form3602A, fill in and stamp it with the tax authority, and mail it to the FDA. Reply within 60 days. 3. The payment of audit fees is approximately $11594 for the latest audit fees in 2020, and $2899 for small business exemptions. 4. 510k file preparation 5. Interpret the applicable standards and regulations of the product through product codes, regulatory numbers, etc.: ISO10993, ASTM, ISO11135, and FDA's series of guidelines: biocompatibility, sterility, and performance testing. Establish performance testing reports, biocompatibility evaluations, sterility verification documents, packaging and transportation verification, and shelf life verification documents. 6. Prepare a complete set of 510k files based on the 510k checklist. Download the 510keCopy verification software, confirm that the file format is correct, and then submit it. 7. The 510K file will be submitted to CDRH via eCopy for FDA response within approximately 60 days. Obtain a 510k certificate or request an addition. If additional documents are required, they should be completed and submitted via eCopy within 180 days. 8. MDUFA system registration, only the 510K status of the enterprise product registration is active. The registration fee for 2020 was $5236 per product. Note: If the product is sold to the US market, it is necessary to prepare for a CFR820 system audit. To understand the accurate price, please bring product information and click on the online customer service on the right for consultation. They will make corresponding quotations based on your product

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