Medical Devices

Draft Guidance

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Draft Guidance Documents

TitleOrganizationDoc #Date
Product Labeling for Certain Ultrasonic Surgical Aspirator Devices - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 322KB) ODE 1500072 11/10/16
Software as a Medical Device (SaMD): Clinical Evaluation (PDF - 801KB) OCD 10/14/16
Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 435KB) CDRH CDER 1400061 09/21/16
510(k) Third Party Review Program - Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations (PDF - 1.1MB) OIR ODE 1500013 09/12/16
Deciding When to Submit a 510(k) for a Software Change to an Existing Device - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 784KB) CDRH CBER 1500055 08/08/16
Deciding When to Submit a 510(k) for a Change to an Existing Device - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 1.6MB) CDRH CBER 1500054 08/08/16
Medical X-Ray Imaging Devices Conformance with IEC Standards - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 509KB) OIR/DRH OSEL/DIDSR 1400014 08/03/16
Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 542KB) CDRH CBER 1500012 07/27/16
Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI) - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 384KB) CDRH CBER 1500035 07/26/16
Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 1.1MB) CDRH CDER CBER 1400027 07/15/16
Use of Public Human Genetic Variant Databases to Support Clinical Validity for Next Generation Sequencing (NGS)-Based In Vitro Diagnostics - Draft Guidance for Stakeholders and Food and Drug Administration Staff (PDF - 499KB) CDRH/OIR CBER 16008 07/08/16
Use of Standards in FDA Regulatory Oversight of Next Generation Sequencing (NGS)-Based In Vitro Diagnostics (IVDs) Used for Diagnosing Germline Diseases - Draft Guidance for Stakeholders and Food and Drug Administration Staff (PDF - 707KB) CDRH/OIR CBER 16009 07/08/16
Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 1.2MB) CDRH CBER 1500626 06/20/16
Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 722KB) OC 1500065 06/16/16
Dissemination of Patient-Specific Information from Devices by Device Manufacturers - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 355KB) OCD 1500067 06/10/16
FDA Categorization of Investigational Device Exemption (IDE) Devices to Assist the Centers for Medicare and Medicaid Services (CMS) with Coverage Decisions - Draft Guidance for Sponsors, Clinical Investigators, Industry, Institutional Review Boards and Food and Drug Administration Staff (PDF - 251KB) CDRH CBER 1500074 06/01/16
Infectious Disease Next Generation Sequencing Based Diagnostic Devices: Microbial Identification and Detection of Antimicrobial Resistance and Virulence Markers - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 1.4MB) OIR/DMD 1500016 05/13/16
Technical Considerations for Additive Manufactured Devices - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 710KB) CDRH CBER 1400002 05/10/16
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
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
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
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
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
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
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
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 - 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 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 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

Page Last Updated: 11/28/2016
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