New FDA Medical Device Guidance Documents for the 2nd Quarter 2013

Document Center Inc. is pleased to announce that the following New FDA Medical Device Guidance documents are available now:

• 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• Molecular Diagnostic Instruments with Combined Functions - Draft Guidance for Industry and Food and Drug Administration Staff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• Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing' - Draft Guidance for Industry and Food and Drug Administration Staff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• Center for Devices and Radiological Health Appeals Processes: Questions and Answers About 517A - Draft Guidance for Industry and Food and Drug Administration Staff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• Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff - FDA Decisions for Investigational Device Exemption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• Content of Premarket Submissions for Management of Cybersecurity in Medical Devices - Draft Guidance for Industry and Food and Drug Administration Staff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• Implanted Blood Access Devices for Hemodialysis - Draft Guidance for Industry and Food and Drug Administration Staff
• Draft Guidance for Industry and Food and Drug Administration Staff - Medical Device Reporting for Manufacturers

Remember, Document Center Inc. is here to help you with not only your standards requirements, but also with regulatory information as well.  Make us your Standards Experts!