Is FDA registration free?
FDA medical-device establishment registration is generally not free. Most establishments required to register must pay the annual fee, although narrowly defined waivers or exemptions may apply in specific circumstances.
Answer
Most medical-device manufacturers, contract manufacturers, sterilizers, specification developers, relabelers, repackagers, remanufacturers, and initial importers must pay an annual establishment-registration fee. For FY 2026, the fee is $11,423 per registrable establishment.
Device listing does not have a separate per-product listing fee. However, listing is generally completed only after the establishment-registration requirements and applicable premarket requirements have been satisfied. Premarket submissions such as 510(k), De Novo, and PMA applications carry separate user fees.
Being a small business does not automatically make establishment registration free. Qualified small businesses can receive reduced fees for many premarket submissions. For FY 2026, FDA may also grant an annual registration-fee waiver—excluding initial registration—to certain qualified small businesses that demonstrate financial hardship under the Small Business Determination program. Eligibility requires FDA qualification and supporting documentation; it should not be assumed.
Some businesses pay no registration fee because their activities do not require establishment registration. Examples may include domestic distributors that do not import, wholesale distributors that are not manufacturers or importers, and component suppliers that distribute only to finished-device manufacturers.
Companies should first determine whether each facility is required to register. If registration is required, the payment, electronic registration, and confirmation steps must all be completed before FDA considers the establishment properly registered.
Trust Our Expert Answers?