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FDA MedDev Guidance


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MedDev Guidance      (US-FDA)

 

 

 

Title Organization Doc # Date
Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices - Draft Guidance for Industry and Food and Drug Administration Staff2 ODE/DOENTD 1836 04/17/14
Live Case Presentations During Investigational Device Exemption (IDE) Clinical Trials - Draft Guidance for Institutional Review Boards, Industry, Investigators, and Food and Drug Administration Staff3 ODE/POS/IDE 1736 04/17/14
Types of Communication During the Review of Medical Device Submissions - Guidance for Industry and Food and Drug Administration Staff4 CDRH CBER 1804 04/04/14
Medical Device Tracking - Guidance for Industry and Food and Drug Administration Staff5 OC 169 03/27/14
Premarket Assessment of Pediatric Medical Devices - Guidance for Industry and Food and Drug Administration Staff6 CBER, CDRH/ODE 1220 03/24/14
Premarket Notification [510(k)] Submissions for Bipolar Electrosurgical Vessel Sealers for General Surgery - Draft Guidance for Industry and Food and Drug Administration Staff7 ODE/DSD/GSDB2 1300048 03/24/14
Premarket Notification [510(k)] Submissions for Electrosurgical Devices for General Surgery - Draft Guidance for Industry and Food and Drug Administration Staff8 ODE/DSD/GSDB2 1835 03/24/14
Humanitarian Device Exemption (HDE): Questions and Answers - Draft Guidance for HDE Holders, Institutional Review Boards, Clinical Investigators, and Food and Drug Administration Staff9 CDRH CBER OOPD 1668 03/18/14
Administrative Procedures for CLIA Categorization - Guidance for Industry and Food and Drug Administration Staff10 OIR 1143 03/12/14
Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff - Guidance for Industry and Food and Drug Administration Staff (PDF - 297KB)11 CDRH CBER 1677 02/18/14
Questions and Answers about eMDR - Electronic Medical Device Reporting - Guidance for Industry, User Facilities and FDA Staff12 OSB/DPS 1679 02/14/14
Annual Reports for Approved Premarket Approval Applications (PMA) - Guidance for Industry and Food and Drug Administration Staff13 CBER CDRH 1585 02/10/14
Class II Special Controls Guideline: John Cunningham Virus Serological Reagents - Guideline for Industry and Food and Drug Administration Staff14 OIR/DMD 1790 01/24/14
Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices) - Draft Guidance for Industry and Food and Drug Administration Staff15 CDRH/OC CDRH/ODE 2206 01/23/14
Reporting of Computational Modeling Studies in Medical Device Submissions - Draft Guidance for Industry and Food and Drug Administration Staff16 ODE OSEL 1807 01/17/14
Custom Device Exemption - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 248KB)17 CDRH/ODE CDRH/OC 1820 01/14/14
Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 521KB)18 OIR/DCTD 1755 01/07/14
Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 524KB)19 OIR/DCTD 1756 01/07/14
Guideline for Industry and Food and Drug Administration Staff - Class II Special Controls Guideline: Temporary Mandibular Condyle Reconstruction Plate20 ODE 1799 12/30/13
Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only - Guidance for Industry and Food and Drug Administration Staff 21 CDRH CBER 1723 11/25/13
Medical Device Development Tools - Draft Guidance for Industry, Tool Developers, and Food and Drug Administration Staff22 CDRH/OCD 1882 11/14/13
Design Considerations for Pivotal Clinical Investigations for Medical Devices - Guidance for Industry, Clinical Investigators, Institutional Review Boards and Food and Drug Administration Staff23 CDRH CBER 1776 11/07/13
Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products - Draft Guidance for Industry and Food and Drug Administration Staff24 ODE 1832 11/07/13
Guidance for Industry and Food and Drug Administration Staff - eCopy Program for Medical Device Submissions (PDF - 501KB)25 CDRH CBER 1797 10/10/13
Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies - Guidance for Industry and Food and Drug Administration Staff (PDF - 1.1MB)26 CDRH CBER 10/01/13
Mobile Medical Applications - Guidance for Industry and Food and Drug Administration Staff (PDF - 269KB)27 CDRH CBER 1741 09/25/13
Global Unique Device Identification Database (GUDID) - Draft Guidance for Industry (PDF - 3.9MB)28 CDRH/OSB CBER 1831 09/24/13
Select Updates for Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems - Draft Guidance for Industry and Food and Drug Administration Staff29 OSEL ODE/DCD 1826 08/30/13
The Applicability of Good Laboratory Practice in Premarket Device Submissions: Questions and Answers - Draft Guidance for Industry and Food and Drug Administration Staff30 CDRH/ODE CBER 1779 08/28/13
IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed31 Guidance for IRBs, Clinical Investigators, and Sponsors: IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed 08/27/13
Radio Frequency Wireless Technology in Medical Devices - Guidance for Industry and Food and Drug Administration Staff32 CDRH/OSEL CBER 1618 08/14/13
Guidance for Industry: Oversight of Clinical Investigations - Risk-Based Approach to Monitoring (PDF - 109KB)33 Procedural 08/06/13
Guidance for Industry and Food and Drug Administration Staff and Foreign Governments - FY 2014 Medical Device User Fee Small Business Qualification and Certification (PDF - 793KB)35 CDRH CBER 2014 08/02/13
Draft Guidance for Industry and Food and Drug Administration Staff - Medical Device Reporting for Manufacturers36 CDRH/OSB/DPS 1828 07/09/13
Implanted Blood Access Devices for Hemodialysis - Draft Guidance for Industry and Food and Drug Administration Staff37 ODE/DRGRUD 1781 06/28/13
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 Specimens38 CDRH/OIR 1788 06/19/13
Content of Premarket Submissions for Management of Cybersecurity in Medical Devices - Draft Guidance for Industry and Food and Drug Administration Staff39 CDRH/OIR CDRH/ODE CBER 1825 06/14/13
Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff - FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations (PDF) (PDF - 564KB)40 CDRH CBER 1783 06/14/13
Guidance for Industry and Food and Drug Administration Staff - Priority Review of Premarket Submissions for Devices41 CBER CDRH 108 05/17/13
Center for Devices and Radiological Health Appeals Processes - Guidance for Industry and Food and Drug Administration Staff42 OCD 1742 05/17/13
Center for Devices and Radiological Health Appeals Processes: Questions and Answers About 517A - Draft Guidance for Industry and Food and Drug Administration Staff43 OCD 1821 05/17/13
Assay Migration Studies for In Vitro Diagnostic Devices - Guidance for Industry and FDA Staff (PDF - 1.2MB)44 CDRH/OIR, CBER 1660 04/25/13