Introduction to the FDA "US Agent" service

According to the FDA medical device enterprise registration and product registration requirements, companies located outside the United States must designate an US agent.

The FDA regulations CFR 807.40 stipulate that when registering with FDA, the only US agent is required to be responsible for the FDA registration and communication with the FDA.

All overseas companies must inform FDA names, addresses and phone numbers of their US agents. US agents must live in the United States or have a business location in the United States, and they must be able to answer the call at normal office hours in the United States.

The responsibilities of the US agent are as follows:

1. Assist the FDA to communicate with foreign companies;
2. Response to the questions of foreign institutional products sold in the United States;
3. Assist the FDA to arrange for inspection of foreign companies;
4. If the FDA cannot contact directly or in time with foreign companies, the FDA may provide information or files to the US agent. Such behaviors should be equivalent to providing the same information or files to foreign companies.

We have independent companies in the United States to engage in FDA registration related businesses. Our US agent service has a history of nearly 20 years and has won the favor of many customers. If you are seeking a stable and reliable service, you are welcome to contact us at any time. The replacement of US agent does not need to notify his predecessor.

Introduction to the FDA "510K Application" service

The FDA divides medical devices into three classes (I, II, III) depending on the risk level, and class III is the highest risk level.

A small amount of class I and class III, most class II medical devices to be sold in the United States need to make a "Premarket Notification"(PMN) certification.

The application documents required for the PMN must meet the US regulations FD&C Act chapter 510, so people usually refers to this application as 510(k) certification application (or 510K application).

The process of this application is as follows:

1. Formulate the 510(k) application information list in accordance with the customer's products and the guidance principles of the FDA related regulations;
2. Select comparison products, according to the preliminary materials provided by customers (such as instructions, product manuals, etc.);
3. Prepare test samples;
4. Apply for DUNS code;
5. Test preparation, contact the testing agency, obtain the quotation, explain the test items and test requirements, etc.;
6. Prepare 510(k) materials listed on the application information list;
7. Product test, which the laboratory is responsible for testing products;
8. Write the 510(k) application documents and submit the documents to the FDA;
9. FDA accepts administrative review;
10. FDA technology review (first time);
11. FDA technology review (interaction).

The 510K application cycle is generally about 100 days. After the application is successful, the customer will get one (or several) K numbers. With this K number, your products can be successfully completed in the US clearance and listing.

You can see that there is some difficult through the application process. Especially the application documents have a certain technical content, which directly determines whether the application is smooth and successful. For more than a decade, we have countless successful cases. We're your trusted FDA 510K application partner.