U.S. FDA
Q-Submission Program
FDA Q-Submission (Q-Sub) Program provides medical device manufacturers with the opportunity to engage in discussions by asking specific questions with FDA review teams during the product development process. Pre-Submissions are the original and most common type of Q-Submission; they permit companies to receive guidance from FDA review teams prior to a premarket submission (i.e. 510(k), PMA) or IDE. A Pre-submission includes a formal written request from a submitter for feedback from FDA that is provided in the form of a formal written response.
Pre-submission Summary
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Specific questions to FDA will depend on each manufacture's situation but some examples can be following,
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Specific non-clinical testing questions
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Specific labeling (product labels and instructions for use) questions
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Specific clinical data requirement questions
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Specific pre-market submission strategy
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Successful pre-submission can result in following,
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Understanding FDA’s expectation can allow both the manufacture and FDA to be aligned on the expected data requirements
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Manufacture will be able to focus on important areas of their development and regulatory strategy
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Manufacture can save time and money to be more efficient
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Manufacture can establish a working relationship with FDA and reference point for future premarket submission
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Theproject provides FDA pre-submission consulting service to obtain FDA feedback prior to 510k submission. Theproject will work together with the manufacture and develop a pre-submission package that will ask specific questions and receive feedback FDA.
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