Frequently Asked Questions

When should a Dual Submission be submitted?

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Compliance & Regulatory: MedTech

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.