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What constitutes a complete 510(k) eSubmission to the Office of In Vitro Diagnostics (OIVD)?

April 26, 2017COMPLETE constitutes Diagnostics esubmission Office OIVD Vitro

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What constitutes a complete 510(k) eSubmission to the Office of In Vitro Diagnostics (OIVD)?

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A complete 510(k) eSubmission for OIVD includes the CD containing only the zip file generated from the CeSub eSubmitter software, a printed and signed Submittal Letter generated from the CeSub eSubmitter software, and previously paid MDUFMA fees.

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A complete 510(k) eSubmission for OIVD includes the CD containing only the zip file generated from the FDA eSubmitter software, a printed and signed Submittal Letter generated from the FDA eSubmitter software, and previously paid MDUFMA fees.