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In this section: Biologics Procedures (SOPPs)

Section 8700: Medical Devices

SOPP 8704: Managing MDUFA User Fee Payments and Billing Activities
Effective Date: March 21, 2024

SOPP 8795: Posting and Announcement of Premarket Approval Application and Humanitarian Device Exemption Approvals and Denials
Effective Date: June 3, 2024

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