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  • Writer's pictureDalia Givony

Consulting with FDA under the Pre-Sub process before submitting a 510(k)/ De Novo​


Consulting with FDA under the Pre-Sub process before submitting a 510(k)/ De Novo​

To obtain feedback from the FDA on the validation process and ensure alignment with FDA requirements, manufacturers often engage with the FDA through the Pre-Submission (Pre-Sub) process. Here are the steps you might consider:


  1. Prepare a Pre-Submission Package:Include a cover letter explaining the purpose of the submission.Provide detailed information about your device, intended use, and indication for use. Include a description of your device, proposed predicate device (if applicable), and the validation process.

  2. Specify Validation Process:Clearly outline your validation process, including any preclinical and clinical studies. Describe the testing methods, protocols, and standards you plan to follow.

  3. Formulate Specific Questions:Identify specific questions related to the validation process that you would like the FDA to address.Questions might include whether the proposed validation methods are appropriate and whether they align with FDA requirements.

  4. Request Feedback Method:Specify how you would like to receive feedback, whether through a written response, a face-to-face meeting, or a teleconference with the FDA.

  5. Submit the Pre-Submission Package:Submit the Pre-Submission package to the FDA and await their response.

  6. Engage in Discussion:If necessary, engage in further discussions with the FDA to clarify any questions or concerns they may have regarding the validation process.

  7. No Fee Requiremments: It is important to note that there is no fee required to submit a Pre-Sub.


By following these steps, manufacturers can proactively seek feedback from the FDA, ensuring that their validation process aligns with regulatory requirements. This engagement helps to identify potential issues early in the development process, facilitating a smoother path to regulatory clearance and reducing the time to market.

Keep in mind that FDA guidance and processes may evolve, so it's advisable to consult the latest guidance documents or seek advice from regulatory experts for the most up-to-date information. Additionally, working with regulatory consultants can be beneficial in navigating the regulatory landscape and ensuring compliance with FDA requirements.


Need help in defining the validation method, clinical study protocol, and in Pre-Sub preperation?




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