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Case Study.

US FDA 510(k) Market Clearance.

A company faced the challenge of launching a new product in the US, where US FDA 510(k) market clearance was critical to market entry.

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The Challenge.

The launch of a new product on the US market presented the company with several challenges:

  • Product launch with a fixed timeframe: The market launch was to take place at a medical congress in the USA, but promotion or sale was not possible without FDA clearance.
  • A lack of experience with US FDA requirements at the customer's company made the process more difficult.
  • CE certification not yet completed: Some documentation for CE approval was still outstanding.
  • Marketing claims and clinical substantiation: Uncertainty about the clinical evidence for specific diagnostic indications made planning difficult.

The Benefits.

  • Product classification according to US CFR and identification/confirmation of the 510(k) as an appropriate approval pathway.
  • Clarification of US-specific requirements, gap analysis regarding the use of existing EU MDR documentation ("document due diligence") and preparation and creation of comprehensive documentation.
  • Clarification of marketing claims with the FDA (Q-Sub process) for the use of planned claims.
  • Project management for 510(k): Scheduling, resource management and budget control.
  • Preparation of the submission and submission to the FDA: Interactive preparation with the client's team.
  • Communication and clarification of queries from the FDA during the review, preparation of a SIR (Submission Issue Request) if necessary.

The Outcome.

Increased predictability of schedules.

The project was efficiently managed through backward planning, which meant that the time frame and budget were adhered to.

Successful and timely submission.

Thanks to precise project planning and regular meetings, the 510(k) submission was completed without delay.

Ensuring a smooth product launch.

The 510(k) clearance was granted on schedule and the product was launched at the medical congress in the USA as planned.

The Result.

Through targeted planning, close cooperation with the FDA and optimization of the documentation processes, the company was able to achieve timely FDA 510(k) clearance and successfully launch the product on the US market.

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