Vaccines, Blood & Biologics
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Section 8700: Medical Devices
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SOPP 8704: Managing MDUFA User Fee Payments and Billing Activities Effective Date: May 19, 2010 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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