Medical Devices

Draft Guidance

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Draft Guidance Documents

TitleOrganizationDoc #Date
Clinical Considerations for Investigational Device Exemptions (IDEs) for Neurological Devices Targeting Disease Progression and Clinical Outcomes - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 147KB) OSEL ODE/DNPMD/NDB 1500021 03/07/16
Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 149KB) ODE OSB 1500051 03/04/16
Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 243KB) ODE/DOD 1300006 02/12/16
Display Devices for Diagnostic Radiology - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 162KB) OIR/DRH OSEL/DIDSR 1500022 02/09/16
List of Highest Priority Devices for Human Factors Review - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 359KB) ODE 1500052 02/03/16
Enforcement Policy on National Health Related Item Code and National Drug Code Numbers Assigned to Devices - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 197KB) CDRH CBER 1500044 02/03/16
Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 593KB) CDRH CBER 1500015 01/26/16
Postmarket Management of Cybersecurity in Medical Devices - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 1.1MB) CDRH CBER 1400044 01/22/16
Unique Device Identification: Convenience Kits - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 336KB) CDRH CBER 1500010 01/04/16
Public Notification of Emerging Postmarket Medical Device Signals ("Emerging Signals") - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 446KB) OCE OSB 1500027 12/31/15
Electroconvulsive Therapy (ECT) Devices for Class II Intended Uses - Draft Guidance for Industry, Clinicians and Food and Drug Administration Staff (PDF - 315KB) ODE/DNPMD 1823 12/29/15
Class II Special Controls Guideline: In Vitro Diagnostic Devices for Bacillus spp. Detection - Draft Guideline for Industry and Food and Drug Administration Staff (PDF - 674KB) OIR/DMD 1400038 11/17/15
Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 325KB) OSEL/DBP ODE OIR 1400057 11/02/15
Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use (PDF - 113KB) Pharmaceutical Quality/CMC 10/21/15
Manufacturing Site Change Supplements: Content and Submission - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 684KB) CDRH/OC CBER 1269 10/21/15
General Considerations for Animal Studies for Medical Devices - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 418KB) ODE OC 1802 10/14/15
Homologous Use of Human Cells, Tissue, and Cellular and Tissue-Based Products; Draft guidance for Industry and FDA Staff (PDF - 120KB) 10/30/15
Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 1MB) OIR/DMD 1740 08/14/15
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
Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance (MR) Environment for Multi-Configuration Passive Medical Devices - Guidance for Industry and Food and Drug Administration Staff (PDF - 394KB) OSEL/DBP 1500001 03/22/16
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
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
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
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
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
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
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 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
Presenting Risk Information in Prescription Drug and Medical Device Promotion (PDF - 1.2MB) Advertising 05/27/09
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: 04/19/2016
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