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U.S. Department of Health and Human Services

Medical Devices

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MDUFMA Guidances

Assessing User Fees
Bundling
Combination Products
Dispute Resolution
Expedited Review
Inspections by an Accredited Person
Pediatric Medical Devices
Premarket Notification Submissions (510(k)s)
Premarket Approval Applications (PMAs)
Reprocessed Single-Use Medical Devices
Section 301 (requirement to identify manufacturer on the device)