FDA classifies medical devices into Class ⅰ, Class ⅱ and Class ⅲ according to the level of risk. Class ⅰ is the lowest risk, and Class ⅱ products belong to medium risk products, which need to obtain FDA 510 (K) number before obtaining FDA enterprise registration. What are the benefits of 510 (K)? How can manufacturers apply? Lanhine medical already get the 510K for 2 years for surgical face mask level2, level3 .
I. Benefits of 510 (K) Application:
1. FDA(K) is a one-time fee without any subsequent fees;
2. If the company makes any changes, the K number will remain unchanged, which is a permanent intangible fixed asset of the company;
3. No need to do any work after K is approved, and it will be held permanently;
4. When a company is listed or acquired, it is usually valued at least 10 times the price of its fixed assets;
Ii. FDA510 (K) Application Process:
1. First, determine whether the device is a medical device according to the definition of FDA regulations;
2. If you can apply for SME qualification, the product registration fee can be reduced to half of the price. The FDA requires manufacturers to fulfill 21 CFR 820 system requirements on their own;
3. Classify the products into class ⅰ, class ⅱ and class ⅲ. The vast majority of Class I products and a small number of Class II products are exempt from premarket notification and do not require FDA registration;
4. Confirm the product entry route 510(k), PMA or exemption, and usually do 510(k);
5. Prepare 510(K) document list, prepare and review documents. 510(K) is divided into traditional, special and abbreviation;
6. Submit documents to the FDA, generally within 1 to 2 months for review comments, and within 3 to 6 months for approval. FDA will formally ask questions no more than 2 times and require a response within a specified time; otherwise, the registration will be considered unsuccessful. Applicants can also apply for an extension of six months after processing, after the extension has not answered the questions, will be considered as the registration failed;
7. After 510 (K) clearance, FDA will publish the product and K number information into the database for anyone to check;
After approval of 8.510(K), FDA will send the applicant a formal letter of approval, only one copy. After receiving the license letter, the manufacturer needs to complete the enterprise listing and product registration on the website;
9. If the product involves major changes, you need to submit a change application. The process starts again and assigns a new K number when it is finished.
10. Every year manufacturers pay an annual fee to the FDA to renew their registration.
Post time: Aug-23-2022