FDA Registration of Medical Devices Intended for the United States

For the year 2025/2026, the annual fee for FDA registration of medical devices is $11,423

You may qualify for an exemption from paying the FDA registration fee if:

• You have registered sales equal to or less than 1 million dollars in the last fiscal year;
• You can demonstrate that paying the registration fee would constitute a significant financial burden; You had already paid the FDA registration fee in a previous fiscal year.

For the purpose of the registration fee exemption, for actively registered businesses, the FDA accepts requests until October 31. For example, requests related to the status for the fiscal year 2026 (which runs from October 1, 2025, to September 30, 2026) will be accepted from August 1, 2025, to October 31, 2025

For FDA registration of medical devices, you need to know the FDA classification code/category of the device itself. The FDA registration for medical devices to be imported into the United States is mandatory.

Classification of Medical Devices

This is why before proceeding with registration, it is essential to conduct research to determine the FDA classification of the medical device to be registered. The annual registration fee for 2024 is $7,653 [The FDA's fiscal year starts on September 30]

Registration Procedure

FDA registration is divided into two parts:

• Registration of the manufacturer or exporter of the medical devices;
• Registration of the individual medical devices to be exported to the United States

FDA Agent

Companies registering must also appoint an FDA Agent to handle communications between the FDA and the manufacturing and/or exporting company. The FDA Agent [this is the original definition] must be an individual or a company with an address and contact in the United States.

Registration Fee

In the context of medical device regulation, the FDA (Food and Drug Administration) requires companies to pay an annual registration fee [which for the year 2024, as we mentioned, is set at $7,653]

Other Types of FDA Fees

In addition to this annual registration fee, there are also other fees applicable depending on the authorization procedure requested from the FDA. Below is a breakdown of fees by type of request or registration, including standard fees and reduced fees for small businesses:

• Procedure 510(k) for Class II medical devices that already have an equivalent on the American market: The standard fee is $21,760, while the fee for small businesses is $5,440.
• Procedure 513(g): The standard fee is $6,528, with a reduced fee for small businesses of $3,264.
• PMA (Premarket Approval) for Class II medical devices that do not have an equivalent on the American market: The standard fee is $483,560, while the fee for small businesses is $120,890.
• Request for De Novo Classification: The standard fee is $145,068, with a reduced fee of $36,267 for small businesses.
• Supplement for Panel-track Supplement in authorization procedures: The standard fee is $386,848, with a reduced fee of $96,712 for small businesses.

It's important for medical device manufacturers to carefully consider these fees in the context of their financial and strategic planning. ExportUSA has been supporting Italian companies in the FDA registration of their medical devices for years, both in the preliminary activity of classifying all medical devices to be imported into the United States.

ExportUSA also provides the FDA agent service for the American market.