• English Services 01

    Achieving and Maintaining Regulatory Compliance is our speciality.

  • English Services 02

    Tailored Solutions
    for your Regulatory

Depending on the classification of the medical device you would like to export to the USA, either a 510(k) or Pre - Market Approval (PMA) by the Food and Drugs Administration (FDA) will be required. The product classification method applied by the FDA differs significantly from the one used in the EU. It is crucial to know at an early stage of the project how your product is classified in the USA because this will have an enormous impact on the strategy for market approval. The compliance and the resources requirements for a 510(k) or a PMA route are considerably different. BioTop Medical can assist you to dertermine the classification of the device, the selection of the applicable standards and guidelines as well as with setting up the necessary documentation to be submitted to the FDA for each path.

An important aspect of the whole process is good communication. BioTop Medical has extensive experience in communication with all stakeholders in the development and production of medical devices, including the FDA reviewers. Clear-cut, simple and precise wording is used to ensure that the necessary details are shared in a practical and appropriate fashion preventing unwanted delays on the critical path to market approval.