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When should a Dual Submission be submitted?

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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 Dual Submission should be submitted following a Pre-Submission. As described in the Medical Device User Fee Amendments of 2017 (MDUFA IV) Commitment Letter, an applicant should inform FDA that it plans to submit a Dual Submission during a Pre-Submission. FDA recommends using this Pre-Submission to discuss planned study designs for comparison and reproducibility studies that support both 510(k) clearance and CLIA waiver.

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