Hello! fda510k certification should refer to the FDA registration process for medical devices: some products are exempt from obtaining a 510K (premarket notification) directly for registration. And some other products are required to obtain 510k (premarket notification) before registration. Specific regulatory requirements and the difference between the two are as follows:
A, FDA regulatory requirements
The U.S. Food and Drug Administration (FDA) regulations require that: all companies engaged in the manufacture, compounding, dissemination, synthesis, assembly, processing, or import and export medical devices must be registered with the FDA. registration. In addition, non-U.S. companies must submit to the FDA the name, address, and telephone number of a U.S. agent who will contact the FDA.
Second, medical device classification
Currently the FDA for medical device registration is divided into three categories:
(1) a class of medical devices
belong to the lowest risk level of the product, most of which can be directly registered, such as Eyeglasses, swabs, etc.
(2) Class II medical devices
Higher-risk products, most Class II products and a small number of Class I high-risk products are required to carry out a pre-market notification (510k) to get the 510k number before you can be registered, such as contact contact lenses, masks, etc.
< p>(3) Class III medical devicesProducts with the highest risk level need to do Pre-market Approval (PMA - Pre-market Approval), e.g., artificial heart, cochlear implants, etc. The higher the risk level, the more difficult it is to obtain approval.
The FDA not only categorizes products into three main groups, but also codes each detailed classification and publishes its definitions and regulations. For example, in the case of masks during the epidemic, the FDA currently has almost a dozen Product codes for masks that are categorized, certain are Class I, certain are Class II but exempted from 510k, and certain require 510k to be listed.
Three, medical devices for the FDA process
The first step in registration is to determine whether your product is under the jurisdiction of the U.S. FDA? If so, which specific classification Product code. After determining the product code, you will need to register according to the requirements of the product code.
1, if the official website has been announced is the first class of products, you can directly enter the FDA medical device online registration system to apply for an account and directly pay the registration fee;
2, if it is required to be 510k products, you need to get a 510k number before you can register.
The 510k (premarket notification) application process is relatively complex, including but not limited to applicable standards and testing programs, comparative counseling for similar products, preparation of technical documents, reporting to the FDA and payment of the official fee for the application of the 510k number (the cost varies from year to year).
After the completion of the review of the FDA is completed, to confirm that the product's risk level and the current U.S. market risk level of similar products are consistent, then you can assign the 510k number. After the FDA has reviewed the product and confirmed that the risk level of the product is consistent with the risk level of similar products currently on the U.S. market, a 510k number is assigned. After getting the 510k number, as in the previous case, then enter the FDA medical device online registration system to apply for an account and pay the registration fee.
3, if it is class III PMA, you need to complete the PMA application, PMA application includes, but is not limited to, the device without "substantial equivalence" (SE), "new product", "new product", "new product", "new product", "new product", "new product", "new product", "new product", "new product", "new product", "new product", "new product", "new product". -The PMA application includes, but is not limited to, the absence of "substantial equivalence" (SE) of the device, "new product", the absence of "substantial equivalence" evaluation benchmarks, and clinical data demonstrating the safety and efficacy of the device. After obtaining this, then enter the FDA medical device online registration system to apply for an account and pay the registration fee.
For more information about FDA medical device registration/certification and fees, please contact us at #Registrar Corp#
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