Mise à jour de guides FDA – 2015

Liste des guides FDA mis à jour ou parus en 2014.

Dernière mise à jour le : 07.04.2014

 

Identifiant Désignation Date de MaJ Lien
413 Procedures for Meetings of the Medical Devices Advisory Committee 01/04/2015  PDF
1685 Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment 11/12/2014 PDF
1694 Infusion Pumps Total Product Life Cycle 02/12/2014 PDF
1737 In Vitro Companion Diagnostic Devices 06/08/2014 PDF
1738 FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs) 03/10/2014  PDF
1739 Framework for Regulatory Oversight of 7 Laboratory Developed Tests (LDTs) 03/10/2014  PDF
1741 Acceptance of Medical Device – Clinical Data from Studies Conducted Outside the United States 22/04/2015  PDF
1748 Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling 17/03/2015 PDF
1750 Design Considerations for Devices Intended for Home Use 24/11/2014 PDF
1763 Molecular Diagnostic Instruments with Combined Functions 12/11/2014  PDF
1766 The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] 28/07/2014 PDF
1768 Recommendations for Labeling Medical Products to Inform Users that the Product or Product Container is not Made with Natural Rubber Latex 02/12/2014 PDF
1770 Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types 20/01/2015  PDF
1806 Policy Clarification for Certain Fluoroscopic Equipment Requirements 25/09/2014  PDF
1808 Transfer of a Premarket Notification (510(k)) Clearance – Questions and Answers  22/12/2014  PDF
1810 Minimizing Risk for Children’s Toy Laser Products 19/12/2014 PDF
1819 Distinguishing Medical Device Recalls from Medical Device Enhancements 15/10/2014  PDF
1820 Custom Device Exemption 24/09/2014  PDF
1821 Center for Devices and Radiological Health Appeals Processes: Questions and Answers About 517A 30/07/2014 PDF
1825 Content of Premarket Submissions for Management of Cybersecurity in Medical Devices 02/10/2014  PDF
1827 Leveraging Existing Clinical 1 Data for Extrapolation to 2 Pediatric Uses of Medical Devices 06/05/2015  PDF
1831 Global Unique Device Identification Database (GUDID) 11/06/2014 PDF
1833 Expedited Access for Premarket Approval and De Novo Medical Devices Intended for Unmet Medical Needfor Life Threatening or Irreversibly Debilitating Diseases or Conditions 13/04/2015  PDF
1300013 General Wellness: Policy for Low Risk Devices 20/01/2015  PDF
1300046 Intent to Exempt Certain Class II and Class I Reserved Medical Devices from Premarket Notification Requirements 01/08/2014  PDF
1400019 Class II Special Controls Guideline: Nucleic Acid-Based In Vitro Diagnostic Devices for the Detection of Mycobacterium tuberculosis Complex and Genetic Mutations Associated with Mycobacterium tuberculosis Complex Antibiotic Resistance in Respiratory Specimens 22/10/2014  PDF
1400030 Content and Format for Abbreviated 510(k)s for Early Growth Response 1 (EGR1) Gene Fluorescence In-Situ Hybridization (FISH) Test System for Specimen Characterization Devices 26/09/2014  PDF
1400045 Radiation Biodosimetry Devices 30/12/2014  PDF
1400051 Class II Special Controls Guideline: Multiplex Nucleic Acid Assay for Identification of Microorganisms and Resistance Markers from Positive Blood Cultures 27/05/2015  PDF
1400052  Immediately in Effect Guidance Document: Product Labeling for Laparoscopic Power Morecellators 25/11/2014  PDF
1400054 Mitigating the Risk of Cross – Contamination from Valves and Accessories Used for Irrigation through Flexible Gastrointestinal Endoscopes 20/01/2015 PDF
1500005 Adaptive Designs for Medical Device Clinical Studies 18 /05/2015  PDF
1500006 Patient Preference Information – Submission, Review in PMAs, HDE Applications, and De Novo Requests, and Inclusion in Device Labeling 18/05/2015  PDF