FDA Introduction
The US Food and Drug Administration (FDA) is one of the executive agencies established by the US government in the Department of Health and Human Services (DHHS) and the Department of Public Health (PHS). As a scientific management agency, the FDA’s responsibility is to ensure the safety of food, cosmetics, drugs, biologics, medical devices and radioactive products produced or imported into the United States. In other words, food, cosmetics, drugs, biologics, medical devices and radioactive products sold in the United States must be approved by the FDA.
What is a US agent?
The US FDA stipulates that foreign medical device, food, alcohol, drug and other factories must register before entering the United States, and must appoint a US agent who is responsible for emergency and daily affairs communication. A US agent refers to a person who has a business location in the United States or in the United States, and is designated as a registered agent by a foreign factory for FDA registration. A US agent cannot be just an email address, voice phone, or a place where the personal address of the foreign factory agent does not exist at all. The U.S. agent acts as a communication link between the FDA and foreign factories, responsible for emergency and daily affairs communication. When an emergency occurs, the FDA will contact the U.S. agent unless another is designated as an emergency contact during registration. The U.S. agent represents the foreign factory, and the FDA will regard the U.S. agent’s statements as the foreign factory’s statements, and will consider the information or documents provided to the U.S. agent to be equivalent to the information or documents provided to the foreign factory. Manufacturers can only designate one person as the U.S. agent for FDA factory registration. Designating a U.S. agent for factory registration does not prevent the factory from designating multiple other agents (such as foreign suppliers) for other business activities. The company’s business activities in the United States do not need to be conducted through the agent designated by this registration.
Establishment Registration and Device Listing
All companies related to products sold to the United States, including but not limited to manufacturers, OEMs, sterilization stations, import and export companies, etc., need to register their companies and list their products with the FDA before they can export their products to the United States. Registration and listing need to be completed by the U.S. agent. After you entrust Humiss Inc. to be your U.S. agent, we will complete the company registration and device listing for you. 510k exempt products can directly register the company and list the device. 510k products need to pass the 510k declaration before registering the company and listing the device.
Medical Device FDA Registration Classification Tips
According to the different risk levels, FDA divides medical devices into three categories (I, II, III), among which Class I has the lowest risk level and Class III has the highest risk level.
I. For Class I products (accounting for about 47%), general control (General Control) is implemented, and cGMP specifications must be followed. Most products only need to register and list products to enter the US market.
II. For Class II products (accounting for about 46%), special control (Special Control) is implemented. After registration and listing, companies must comply with cGMP specifications. After registration and listing, they also need to submit 510 (K) applications (very few products are 510 (K) exempted), which is the sales approval of Class II products.
III. For Class III products (accounting for about 7%), pre-market approval is implemented. After registration and listing, the company must implement cGMP specifications and submit a PMA (Premarket Application) application to the FDA (some Class III products are PMN applications)
Note: For Class I and II devices, some products are exempt from cGMP review, while for Class III devices, companies must submit PMN or PMA. At the same time as the announcement, the FDA will give the company a formal market access approval letter (Clearance), which allows the company to directly sell its products in the US medical device market under its own name. As for whether to conduct on-site cGMP assessment at the company during the application process, the FDA decides based on comprehensive factors such as product risk level, management requirements and market feedback.
Medical device FDA registration process
- Humiss Inc. applies for a PIN code (FDA official annual fee payment code) for you;
- You pay the official annual fee to FDA according to the payment operation guide and PIN code given to you by Humiss Inc.;
- After receiving the payment notification and obtaining the PCN code, Humiss Inc. will register your company and list your products in the FDA system according to the application form you filled out;
- After successful registration, the FDA system will immediately generate a company information, Owner number issued by FDA, and product listing number. This information will be displayed in the FDA electronic confirmation. Humiss Inc. will give you the confirmation, and then FDA will issue the Registration number in the order of application time of each company.
- After successful registration, you will be able to query your company information and product information on the FDA registration information official website. The query link is: https://www.accessdata.fda.gov/scripts/cdr h/cfdocs/cfRL/rl.cfm. From October 1 to December 31 each year, you need to pay the official fee for the new fiscal year to the FDA and update it in time to avoid the cancellation of the registration information. HUMISS will contact you in advance to remind you to complete the annual update.
Friendly reminder:
- FDA does not issue any certification documents. After successful registration, we will give you the official downloaded electronic version of confirmation. Before the Registration number is issued, the Owner number can also be used for customs clearance.
- FDA official information query is updated once a week. If you have not found it yet, please check it after next Monday.
Why choose us as your US agent
Humiss Inc. is an American company established in Colorado, USA under the Humiss Group. It was established in 2016 and provides professional US agent services to thousands of manufacturers.
