FDA Guidance Documents Update

Recently posted guidance documents:

1/21/16: CVM GFI #226 - Target Animal Safety Data Presentation and Statistical Analysis

1/21/16: Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile - Guidance for Industry and Food and Drug Administration Staff

1/21/16: Implanted Blood Access Devices for Hemodialysis - Guidance for Industry and Food and Drug Administration Staff

1/22/16: Guidance Agenda: Guidances CDER is Planning to Publish During Calendar Year 2016

1/26/16: Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices - Draft Guidance for Industry and Food and Drug Administration Staff

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