User Fees and Refunds for Premarket Notification Submissions (510k's)
The US FDA requires a user fee for medical device new 510k submission under the medical device user fee amendments (MDUFA). The fee amount depends on whether the applicant qualifies as a standard or small business. To qualify for the small business reduced fee, companies must apply for and receive Small Business Certification from the FDA.
Refunds are not provided once a 510k submission has been accepted for review. However, if a submission is withdrawn before acceptance, a partial refund may be considered. It’s important for applicants to plan carefully and ensure submission quality before filing, as fees are non-transferrable and non-refundable in most cases.
Exemptions from 510k User Fees
All new 510k submissions require payment of a user fee, certain exemptions apply under FDA regulations. The key exemptions include:
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Submissions reviewed by an FDA accredited third parties (Third-party 510k submissions under the Accredited Persons Program) are not subject to user fees. But the third party charge their own fees for initial and additional reviews.
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If the FDA requests a 510K submission (e.g., for a previously exempt device now requiring review), the user fee may be waived.
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De Novo requests (if submitted after a 510k denial) are only need to pay the balance amount or nothing.
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U.S federal agencies are exempt from paying FDA user fees.
Content owner: Ms. Amrutha Rai, Team Lead, 510k Compliance