Medical Devices

MDUFMA Guidances


Assessing User Fees

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Bundling

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Combination Products

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Dispute Resolution

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Expedited Review

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Inspections by an Accredited Person

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Pediatric Medical Devices

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Premarket Notification Submissions (510(k)s)

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Premarket Approval Applications (PMAs)

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Reprocessed Single-Use Medical Devices

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Section 301 (requirement to identify manufacturer on the device)

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Page Last Updated: 06/26/2014
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