Medical Devices

Draft Guidance

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Draft Guidance Documents

TitleOrganizationDoc #Date
Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 751KB) OIR/DRH OSEL/DP 340 07/14/15
Heparin-Containing Medical Devices and Combination Products: Recommendations for Labeling and Safety Testing - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 383KB) ODE 1817 07/09/15
Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 355KB) ODE/DAGHRICDD 1500025 06/30/15
Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance (MR) Environment for Multi-Configuration Passive Medical Devices - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 437KB) OSEL/DBP 1500001 06/29/15
Unique Device Identification: Direct Marking of Devices - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 587KB) CDRH CBER 1400031 06/26/15
Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions - Draft Guidance for Investigational Device Exemption Sponsors, Sponsor-Investigators, and Food and Drug Administration Staff (PDF - 877KB) CDRH CBER 1500017 06/18/15
Adaptive Designs for Medical Device Clinical Studies - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 563KB) CDRH CBER 1500005 05/18/15
Patient Preference Information - Submission, Review in PMAs, HDE Applications, and De Novo Requests, and Inclusion in Device Labeling - Draft Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders (PDF - 776KB) CDRH CBER 1500006 05/18/15
Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 1.1MB) CDRH CBER 1827 05/06/15
Acceptance of Medical Device Clinical Data from Studies Conducted Outside the United States - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 649KB) CDRH CBER 1741 04/22/15
Procedures for Meetings of the Medical Devices Advisory Committee - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 571KB) CDRH/ODE CDRH/OIR 413 04/01/15
Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 644KB) OIR/DMGP/MPCB, OSEL 1400053 02/25/15
Premarket Studies of Implantable Minimally Invasive Glaucoma Surgical (MIGS) Devices - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 726KB) ODE/DOENTD/ICIB 1400049 02/11/15
Medical Devices and Clinical Trial Design for the Treatment or Improvement in the Appearance of Fungally-Infected Nails - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 369KB) ODE/DSD 1400009 01/27/15
Mitigating the Risk of Cross-Contamination from Valves and Accessories Used for Irrigation through Flexible Gastrointestinal Endoscopes - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 596KB) ODE 1400054 01/20/15
General Wellness: Policy for Low Risk Devices - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 550KB) OCD 1300013 01/20/15
Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 309KB) CDRH CBER 1770 01/20/15
Radiation Biodosimetry Devices - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 379KB) OIR/DMGPD 1400045 12/30/14
Transfer of a Premarket Notification (510(k)) Clearance – Questions and Answers Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 357KB) CDRH/ODE CBER 1808 12/22/14
Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories - Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs) (PDF - 312KB) CDRH/OIR CBER 1739 10/03/14
Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories - FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs) (PDF - 565KB) CDRH/OIR CBER 1738 10/03/14
Policy Clarification for Certain Fluoroscopic Equipment Requirements - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 119KB) OIR 1806 09/25/14
De Novo Classification Process (Evaluation of Automatic Class III Designation) - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 344KB) CDRH CBER 1760 08/14/14
Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications [510(k)] with Different Technological Characteristics: Draft Guidance for Industry and Food and Drug Administration Staff CDRH CBER 1818 07/15/14
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Draft Guidance for Industry and Food and Drug Administration Staff CDRH CBER 1770 05/13/14
Surveying, Leveling, or Alignment Laser Products - Draft Guidance for Industry and Food and Drug Administration Staff OIR/DRH 1764 05/05/14
Live Case Presentations During Investigational Device Exemption (IDE) Clinical Trials - Draft Guidance for Institutional Review Boards, Industry, Investigators, and Food and Drug Administration Staff ODE/POS/IDE 1736 04/17/14
Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices - Draft Guidance for Industry and Food and Drug Administration Staff ODE/DOENTD 1836 04/17/14
Premarket Notification [510(k)] Submissions for Electrosurgical Devices for General Surgery - Draft Guidance for Industry and Food and Drug Administration Staff ODE/DSD/GSDB2 1835 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 Staff ODE/DSD/GSDB2 1300048 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 Staff CDRH CBER OOPD 1668 03/18/14
Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices) - Draft Guidance for Industry and Food and Drug Administration Staff 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 Staff ODE OSEL 1807 01/17/14
Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 1.5MB) 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) OIR/DCTD 1756 01/07/14
Medical Device Development Tools - Draft Guidance for Industry, Tool Developers, and Food and Drug Administration Staff CDRH/OCD 1882 11/14/13
Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products - Draft Guidance for Industry and Food and Drug Administration Staff ODE 1832 11/07/13
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 Staff 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 Staff CDRH/ODE CBER 1779 08/28/13
Draft Guidance for Industry and Food and Drug Administration Staff - Medical Device Reporting for Manufacturers CDRH/OSB/DPS 1828 07/09/13
Implanted Blood Access Devices for Hemodialysis - Draft Guidance for Industry and Food and Drug Administration Staff ODE/DRGRUD 1781 06/28/13
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 (PDF - 1.6MB) ODE 1811 04/23/13
Accreditation and Reaccreditation Process for Firms under the Third Party Review Program: Part I - Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Reviewers OIR ODE 1815 02/15/13
Considerations When Transferring Clinical Investigation Oversight to Another IRB CBER CDER CDRH 06/12/12
Draft Guidance for Industry and Food and Drug Administration Staff - Pediatric Information for X-ray Imaging Device Premarket Notifications OIVD/DRD OCER/DMQRP OSEL/DIAM 1771 05/10/12
Draft Guidance for Industry and Food and Drug Administration Staff - Class II Special Controls Guidance Document: In Vitro Diagnostic Devices for Yersinia spp. Detection OIVD/DMD 1714 11/07/11
Draft Guidance for Industry and Food and Drug Administration Staff - Postmarket Surveillance Under Section 522 of the Federal Food, Drug and Cosmetic Act OSB 1754 08/16/11
Draft Guidance for Industry and Food and Drug Administration Staff - Applying Human Factors and Usability Engineering to Optimize Medical Device Design ODE 1757 06/22/11
Draft Guidance for Industry and FDA Staff - Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of methicillin-resistant Staphylococcus aureus (MRSA) for Culture Based Devices OIVD/DMD 1729 06/15/11
Draft Guidance for Industry and Food and Drug Administration Staff - Establishing the Performance Characteristics of In Vitro Diagnostic Devices for Chlamydia trachomatis and/or Neisseria gonorrhoea: Screening and Diagnostic Testing OIVD/DMD 1733 05/11/11
Draft Guidance for Industry and Food and Drug Administration Staff - Establishing the Performance Characteristics of Nucleic Acid-Based In vitro Diagnostic Devices for the Detection and Differentiation of Methicillin-Resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA) OIVD/DMD 1722 01/05/11
Draft Guidance for Industry and Food and Drug Administration Staff - Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Clostridium difficile OIVD/DMD 1715 11/29/10
Draft Guidance for Industry and FDA Staff - Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Helicobacter pylori OIVD/DMD 1712 09/23/10
Draft Guidance for Industry and Food and Drug Administration Staff - Recommendations for Premarket Notifications for Lamotrigine and Zonisamide Assays OIVD/DCTD 1654 08/06/10
Presenting Risk Information in Prescription Drug and Medical Device Promotion (PDF - 1.2MB) Advertising 05/27/09
Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile CBER CDRH/ODE 1615 12/12/08
Coronary Drug-Eluting Stents — Nonclinical and Clinical Studies -Companion Document (PDF - 1.3MB) CDER CDRH 04/07/08
Coronary Drug-Eluting Stents-Nonclinical and Clinical Studies (PDF - 1.7MB) CDRH CDER 03/26/08
Draft Guidance for Industry and FDA Staff - Premarket Notification [510(k)] Submissions for Medical Devices that Include Antimicrobial Agents ODE 1557 07/19/07
Draft Guidance for Industry, Clinical Laboratories, and FDA Staff - In Vitro Diagnostic Multivariate Index Assays CBER CDRH/OIVD 1610 07/26/07
Premarket Notification [510(k)] Submissions for Medical Sterilization Packaging Systems in Health Care Facilities; Draft Guidance for Industry and FDA ODE/DAGID/INCB 1388 03/07/02

Page Last Updated: 07/14/2015
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