The Food and Drug Administration is responsible for regulating the sale of medical devices in the United States. Anyone who wants to sell medical devices in the U.S. must first get approval from the FDA. Part of this process includes registering devices with the FDA.
Registration with the FDA is a two-step process. The first step involves paying an annual registration fee. The second is completing the registration process. Unless a waiver is granted, the Food and Drug Administration Amendments Act of 2007 requires all registrations and listing information to be submitted electronically. The process is considered complete when the FDA sends an e-mail confirming that all of the requirements have been met. Some users may benefit from utilizing a regulatory affairs service to assist with the process.
Users can pay the annual registration fee online. When users make a payment, they are issued a Payment Identification Number and are sent an email confirming their payment. The process may take several days, so it is a good idea to make this payment several days before registering.
Once users have their Payment Confirmation Number, they can proceed to the FURLS Device Registration website. Next, they will create an account and then select the “Register a Medical Device Facility” link. From this point, users follow the instructions, which include entering information about the devices their facility processes, manufacturers, distributes or imports. They will also need to create listings for each device. Once all of the information has been entered, the user must certify that the information is correct and then click the submit button and enter the PIN and PCN numbers they received after making their payment.
Once the initial registration is complete, users need to complete an annual registration to maintain compliance. Additional information can be found on the FDA website.