Things you need to know about FDA 510K submission

by John Smith Digital Marketing Expert

To sell a mid-risk IVD in the United States, the company needs to have a technical dossier. This technical dossier is popularly known as the FDA 510K. Previously known as the Premarket notification, this 510K contains all the necessary information like the dosage, usage, side effects, performance, safety, technical details, etc., about the device or the medicine distributed across the United States. Before you jump out and sell the device, the FDA authority should pass and ‘clear’ the device for sale in the US. The technical details and documentation should satisfy the inspectors from the FDA to ‘clear’ your device. This certification is required for both Class I and Class II devices and all the IVDs.

The process of preparing the 510K for medical devices:

FDA is pretty strict about the format, and if not done properly, they will not clear your form even if the product has good qualities. Twenty different and individual fields are mentioned in the form. Every field must comply with the FDA 510K submission. You will be asked to attach reports, test documents, protocols, etc., with the form. You should submit everything in a neat and clean proper way. The personnel from FDA will check everything minutely and properly. You should do the documentation professionally, and then only you can pass this tough test.

How much time will be required by the FDA to review your product?

Generally, the 510K submission required a lot of documentation. FDA takes around 90 days to go through the report and prepare a review of the device. If the FDA issues an RTA or Refuse to Accept letter or asks for an AI or Additional Information form, the review procedure will stop abruptly. You, as a company owner will get another 180 days following to present the AI with all the required details and information asked by the FDA. If you can submit all the documents properly, the clearance will be received soon.

What to do once the clearance is received?

The FDA will send a 510K clearance letter along with a Unique ID for your device. This clearance number and the letter show that every piece of information given by you perfectly matches the device you want to sell in the US. Now you need to list your product with the FDA. You can check the online procedures. Now, if your company is new, you need to register your company to the US market. You, as a seller, need to pay an annual establishment fee for the company’s registration with the US market.