What is FDA certification?
FDA is the abbreviation for Food and Drug Administration. FDA sometimes also stands for the U.S. Food and Drug Administration. The FDA is authorized by the U.S. Congress, i.e. the federal government, and is the highest law enforcement agency specializing in food and drug management. It is also a government health control monitoring agency composed of professionals such as doctors, lawyers, microbiologists, chemists and statisticians who are committed to protecting, promoting and improving the health of the nation. Many other countries seek and receive assistance from the FDA to promote and monitor the safety of their own products.
What is the fee standard for FDA certification?
The charging standards for FDA certification of medical device products. Medical devices have different risks due to different uses, so they are divided into Class I medical devices, Class II medical devices, and Class III medical devices in terms of risk classification. The fees for applying for US FDA certification for these three risk levels are also very different. In order to make it easier for everyone to avoid confusion, we will introduce them one by one.
(1) Fees for Class I medical devices and Class II medical devices exempted from 510K certification applying for US FDA certification:
FDA manufacturer regulatory fee: $5,236. Agent annual fee: RMB 4,500-10,000;
(2) Fees for Class II medical devices and Class I medical devices that are not exempt from 510K certification and apply for US FDA certification:
FDA manufacturer regulatory fee: $5,236. The 510K report review fee is US$11,594, and the agent's 510K report writing fee ranges from RMB 70,000 to RMB 120,000. If it is a small and micro enterprise, and the qualification certificate provided is acceptable to FDA, the 510K review fee can be handled as a small and micro enterprise, which is only US$2,899. Of course, it must be certified as a small and micro enterprise by FDA.
Fees for device application for US FDA certification:
FDA manufacturer regulatory fee: $5,236. The PMA, PDP, PMR and BLA review fees are US$340,995, and the agent consulting fee ranges from RMB 300,000 to RMB 1,000,000.
Fees for food registration with the US FDA:
The U.S. FDA itself does not charge any fees for food products to obtain FDA certification. However, during the FDA registration application process, these products need an American or a U.S. company to act as an agent, or a third-party contact person. This is a mandatory requirement. It won't work without one. So, if you want someone to be your third-party contact, you must pay a certain fee before they will help you as your agent. There are basically no people who will help you for free or on a voluntary basis.
Fees for laser radiation products applying for US FDA certification and registration:
As laser radiation products involve testing, the charges are difficult to confirm because some laboratories charge very expensive testing fees. For example, TUV charges tens of thousands for testing laser speed and wavelength, while some laboratories only charge more than 10,000, and the cheapest is only 7,000 or 8,000. Therefore, we cannot confirm the exact charging standards for laser radiation products because the error in this regard is too large. However, it is free to apply for FDA certification and registration for laser radiation products. In other words, there is no charge for official registration. The only place where fees are generally incurred is when testing laser and radiation products.
Fees for FDA certification of cosmetics:
Regarding the charging standards for FDA certification of cosmetics, it is actually similar to that of laser products, that is, testing will incur fees. Registration on the US FDA official website is free, and it is completely free. However, although the FDA registration process for cosmetics is free, agent fees will still be incurred. Because it is impossible for American agents to act as agents for Chinese companies, that is, third-party contacts, for free. As for the agent's fee, it generally ranges from 2,000 to 8,000. Testing fee is extra.
This is the end of the knowledge about FDA certification in this issue. If you want to get more information about FDA certification, please pay attention and we will continue to answer you~
