Class II medical devices require a premarket notification, a so called 510(k), when they are submitted to the FDA for approval. The basis for this is the demonstration that the product to be approved is substantially like a comparable product already on the market. The essential features such as specifications, material, technology, intended use and indications must match.
A 510(k) submission requires not only comprehensive technical documentation, but also thorough research of applicable standards and general and specific guidelines. After submission and review of the documentation, a document control number (K-number) is assigned, and an acknowledgement letter is issued to confirm receipt of the documentation. This is followed by the "Notification Letter", which either confirms or does not confirm the equivalence of the product. In the latter case, the manufacturer has 30 days to, for example, reclassify the product or determine new comparator products. If this does not happen, a new registration must be applied for.
Upon registration, a "US Agent" must be appointed who is available to answer questions, especially in connection with the import of the medical device. This function is similar to that of the EC-REP but should not be equated with it.
We are at your disposal if you have any further questions or need active support in the approval process for medical devices in the USA. Please do not hesitate to contact us.
