E-ssentials MedDev Blog

Regulatory updates for the medical device industry

USA: drastic rise in user fees for 510(k) applications

Effective October 1, 2017, US FDA (Food and Drug Administration) has drastically raised the user fees for 510(k) applications submitted directly to the FDA by the manufacturer. The standard fee has more than doubled, from USD 4,690 to USD 10,566. Only for small businesses the fee increase has been relatively moderate, rising by around USD 300 to USD 2,642. But there is good news for TÜV SÜD clients: When a third-party 510(k) review by an accredited person such as TÜV SÜD is chosen, no fees will have to be paid to the FDA.

For the manufacturers of medical devices, the benefits of collaboration with TÜV SÜD – beyond this cost aspect – are evident: familiar contacts, established processes, smooth communication and, above all, significant time savings. While the FDA takes 90 days for the review, TÜV SÜD offers to do it in 30 days.

Are you planning operations for the US market?
Email our experts and get all the information you need regarding marketing your device within the US.

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Georg Bauer

Georg Bauer

Department Manager Foreign Affairs

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