Medical Devices

Draft Medical Device Guidance

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Draft Guidance Documents

TitleIssued Date
Content of Premarket Submissions for Management of Cybersecurity in Medical Devices - Draft Guidance for Industry and Food and Drug Administration Staff10/18/18
The Special 510(k) Program - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 697KB)09/28/18
Recognition and Withdrawal of Voluntary Consensus Standards - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 515KB)09/14/18
510(k) Third Party Review Program - Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations (PDF - 781KB)09/14/18
Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 616KB)09/06/18
Process to Request a Review of FDA's Decision Not to Issue Certain Export Certificates for Devices - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 208KB)08/17/18
Peripheral Vascular Atherectomy Devices - Premarket Notification [510(k)] Submissions - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 400KB)07/27/18
Metal Expandable Biliary Stents - Premarket Notification (510(k)) Submissions - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 507KB)07/18/18
Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings - Labeling Considerations - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 347KB)06/15/18
Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 460KB)06/15/18
Humanitarian Device Exemption (HDE) Program - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 1.2MB)06/13/18
Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 732KB)06/07/18
Recommended Content and Format of Complete Test Reports for Non-Clinical Bench Performance Testing in Premarket Submissions - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 366KB)05/31/18
Multiple Function Device Products: Policy and Considerations - Draft Guidance for Industry and Food and Drug Administration (PDF - 472KB)04/27/18
Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence through Performance Criteria - Draft Guidance for Industry and Food and Drug Administration (PDF - 418KB)04/12/18
Laser Products - Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 (Laser Notice No. 56) - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 118KB)01/19/18
Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 615KB)12/19/17
Investigational IVDs Used in Clinical Investigations of Therapeutic Products - Draft Guidance for Industry, Food and Drug Administration Staff, Sponsors, and Institutional Review Boards (PDF - 731KB)12/18/17
The Least Burdensome Provisions: Concept and Principles - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 513KB)12/15/17
Clinical and Patient Decision Support Software - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 461KB)12/08/17
Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 547KB)12/08/17
Recommendations for Dual 510(k) and CLIA Waiver by Application Studies - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 1.4MB)11/29/17
Select Updates for Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 800KB)11/29/17
Acceptance Review for De Novo Classification Requests - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 1MB)10/30/17
Breakthrough Devices Program - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 257KB)10/25/17
Marketing Clearance of Diagnostic Ultrasound Systems and Transducers - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 741KB)10/02/17
Classification and Requirements for Laser Illuminated Projectors (LIPs) (Laser Notice No. 57) - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 465KB)10/02/17
Utilizing Animal Studies to Evaluate Organ Preservation Devices - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 525KB)09/15/17
Regulatory Considerations for Microneedling Devices - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 441KB)09/15/17
Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers Guidance for Industry (PDF - 458KB)06/12/18
Premarket Notification (510(k)) Submissions for Bone Anchors - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 493KB)01/03/17
Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 435KB)09/21/16
Medical X-Ray Imaging Devices Conformance with IEC Standards - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 509KB)08/03/16
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)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)07/15/16
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)05/13/16
Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 243KB)02/12/16
List of Highest Priority Devices for Human Factors Review - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 359KB)02/03/16
Unique Device Identification: Convenience Kits - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 336KB)01/04/16
Electroconvulsive Therapy (ECT) Devices for Class II Intended Uses - Draft Guidance for Industry, Clinicians and Food and Drug Administration Staff (PDF - 315KB)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)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)10/21/15
Manufacturing Site Change Supplements: Content and Submission - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 684KB)10/21/15
General Considerations for Animal Studies for Medical Devices - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 418KB)10/14/15
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)03/22/16
Transfer of a Premarket Notification (510(k)) Clearance – Questions and Answers Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 357KB)12/22/14
Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs) - Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories (PDF - 312KB)10/03/14
FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs) - Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories (PDF - 565KB)10/03/14
Policy Clarification for Certain Fluoroscopic Equipment Requirements - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 119KB)09/25/14
Surveying, Leveling, or Alignment Laser Products - Draft Guidance for Industry and Food and Drug Administration Staff05/05/14
Live Case Presentations During Investigational Device Exemption (IDE) Clinical Trials - Draft Guidance for Institutional Review Boards, Industry, Investigators, and Food and Drug Administration Staff04/17/14
Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices) - Draft Guidance for Industry and Food and Drug Administration Staff01/23/14
Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products - Draft Guidance for Industry and Food and Drug Administration Staff11/07/13
Class II Special Controls Guidance Document: In Vitro Diagnostic Devices for Yersinia spp. Detection - Draft Guidance for Industry and Food and Drug Administration Staff11/07/11
Presenting Risk Information in Prescription Drug and Medical Device Promotion (PDF - 933KB)05/27/09
Coronary Drug-Eluting Stents — Nonclinical and Clinical Studies -Companion Document (PDF - 1.3MB)04/07/08
Coronary Drug-Eluting Stents-Nonclinical and Clinical Studies (PDF - 1.7MB)03/26/08
Draft Guidance for Industry, Clinical Laboratories, and FDA Staff - In Vitro Diagnostic Multivariate Index Assays07/26/07

Page Last Updated: 10/17/2018
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