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Vaccines, Blood & Biologics

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Section 8700: Medical Devices

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SOPP 8704: Verification of Medical Device User Fee Data Sheet and Payment
Effective Date: January 12, 2005
SOPP 8717: Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices
Effective Date: Date: Jan. 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: 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 Approvals and Denials
Effective Date: September 11, 2007

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