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  5. Section 8700: Medical Devices
  1. Biologics Procedures (SOPPs)

Section 8700: Medical Devices

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

SOPP 8717: Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices
Effective Date: January 13, 2005

SOPP 8725: Procedures for Handling Inquiries Regarding the Need for an Investigational Device Exemptions Application for Research Involving Medical Devices
Effective Date: January 13, 2005

SOPP 8748: Continued Access to Investigational Devices During PMA Preparation and Review
Effective Date: January 11, 2005

SOPP 8770: Deciding When to Submit a 510(k) for a Change to an Existing Device
Effective Date: January 13, 2005

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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