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What is a Pre-Sub?

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About the Author
Proxima CRO Team
Isabella Schmitt, RAC
Director of Regulatory Affairs
Ms. Schmitt has also served in additional regulatory affairs and clinical research roles in which she contributed to multiple regulatory submissions and clinical affairs projects across a wide range of indications.

A Pre-Sub includes a formal written request from a submitter for feedback from FDA that is provided in the form of a formal written response or, if the submitter chooses, formal written feedback followed by a meeting in which any additional feedback or clarifications are documented in meeting minutes.

A Pre-Sub provides the opportunity for a submitter to obtain FDA feedback prior to an intended premarket submission (i.e., IDE, PMA, HDE, De Novo request, 510(k), Dual, BLA, IND), Accessory Classification Request, or CW. The request should include specific questions regarding review issues relevant to a planned IDE, CW, or marketing submission (e.g. questions regarding nonclinical testing protocols, design and performance of clinical studies, etc.). A Pre-Sub is appropriate when FDA’s feedback on specific questions is necessary to guide product development and/or submission preparation.

The program is entirely voluntary on the part of the submitter. So why do it? It's been shown that early interaction with FDA on planned nonclinical and clinical studies and careful consideration of FDA’s feedback may improve the quality of subsequent submissions, shorten total review times, and facilitate the development process for new devices. FDA believes that interactions provided within Pre-Subs are likely to contribute to a more transparent review process for FDA and the submitter. FDA staff develops feedback for Pre-Subs by considering multiple scientific and regulatory approaches consistent with least burdensome requirements and principles to streamline regulatory processes. FDA has found that feedback is most effective when requested prior to execution of planned testing.

Issues raised by FDA in a Pre-Sub do not obligate submitters to addressing or resolving those in a subsequent submission, though any future submission related to that topic should discuss why a different approach was chosen or an issue left unresolved. Further, review of information in a Pre-Sub does not guarantee approval or clearance of future submissions. Additional questions may be raised during the review of the future submission when all information is considered as a whole, or if new information has become available since the Pre-Sub.

Note that for an Accessory Classification Request for an existing accessory type, FDA must provide an opportunity for the submitter to meet with FDA to discuss the appropriate classification of the accessory prior to submission. FDA is also willing to meet with manufacturers who intend to submit an Accessory Classification Request for a new accessory type. FDA recommends that requests for feedback regarding a planned Accessory Classification Request be submitted as a Pre-Sub.

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