An FDA pre-submission (i.e., Q-Sub or pre-sub) meeting allows medical device companies to ask the FDA questions in preparation for a device submission. Whether you plan to submit a 510(k), De Novo, PMA, or even an Investigational Device Exemption (IDE) in the future, an FDA pre-submission is how you ask the FDA questions about your testing plan. The FDA pre-submission is not about your device. You can't ask the FDA for help designing your device, and you can't ask if your data is good enough for submission. What you can do is to ask the FDA specific questions about your testing plans. The pre-submission is an opportunity to forge a better testing plan with the FDA. Therefore, you need to submit detailed testing protocols to the FDA in your pre-submission meeting request and ask specific questions about those protocols.

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