510K Application Notes

  Some issues to pay attention to when applying to FDA

  1. Before applying, it must be clear whether the product is recognized by FDA as a medical device, product category, management requirements, and the content of the application;

  2. Check whether there is a US mandatory standard for the product applying for listing, and whether the product complies with the standard

3. Before preparing the 510(K) application documents, you need to consider whether you really need to submit, when to submit, and what kind of 510(K) application to submit: regular 510(K), special 510(K), simplified 510( K);

  4. Written and timely answers should be given to the questions raised by FDA during the application process;

  5. The paper size of all materials submitted to FDA should be Letter Size (21.5cm X 29.7cm);

  6. All companies that submit materials to the FDA need to keep backup copies, because the FDA will scan and log in electronically after receiving the application materials, and at the same time destroy the application materials, and will not return them to the company.

  7. For a small number of products, the FDA will conduct on-site GMP assessment of the enterprise. The enterprise must refer to the US GMP management requirements, and provide appropriate translators who have a certain understanding of GMP and the enterprise during the FDA on-site audit;

  8. The official contact person who informs the FDA needs to have a certain understanding of the FDA regulations and working procedures, and can communicate directly with the FDA to facilitate timely feedback. The enterprise can specify itself or entrust a consulting agency to be responsible for the daily communication with the FDA.