- Guidance for Industry and Food and Drug Administration Staff - User Fees and Refunds for Premarket Notification Submissions (510(k)s)
- Guidance for Industry and Food and Drug Administration Staff - User Fees and Refunds for Premarket Approval Applications and Device Biologics License Applications
- Molecular Diagnostic Instruments with Combined Functions - Draft Guidance for Industry and Food and Drug Administration Staff
- Medical Device Classification Product Codes - Guidance for Industry and Food and Drug Administration Staff
- Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing' - Draft Guidance for Industry and Food and Drug Administration Staff
- Assay Migration Studies for In Vitro Diagnostic Devices - Guidance for Industry and FDA Staff
- Center for Devices and Radiological Health Appeals Processes: Questions and Answers About 517A - Draft Guidance for Industry and Food and Drug Administration Staff
- Center for Devices and Radiological Health Appeals Processes - Guidance for Industry and Food and Drug Administration Staff
- Guidance for Industry and Food and Drug Administration Staff - Priority Review of Premarket Submissions for Devices
- Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff - FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations
- Content of Premarket Submissions for Management of Cybersecurity in Medical Devices - Draft Guidance for Industry and Food and Drug Administration Staff
- Draft Guideline for Industry and Food and Drug Administration Staff - Class II Special Controls Guideline: Nucleic Acid-Based In Vitro Diagnostic Devices for the Detection of Mycobacterium tuberculosis Complex in Respiratory Specimens
- Implanted Blood Access Devices for Hemodialysis - Draft Guidance for Industry and Food and Drug Administration Staff
- Draft Guidance for Industry and Food and Drug Administration Staff - Medical Device Reporting for Manufacturers
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