Medical Devices

Recent Draft Medical Device Guidance Documents

This list contains the 25 most recent draft medical device guidance documents. For a complete listing, please see the Draft Guidance page.

Recent Draft Guidance

Title Organization Doc # Date
Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies - Draft Guidance for Industry and Food and Drug Administration Staff CDRH CBER 1500626 June 20, 2016
Dissemination of Patient-Specific Information from Devices by Device Manufacturers - Draft Guidance for Industry and Food and Drug Administration Staff OCD 1500067 June 10, 2016
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Device Exemption (IDE) Devices to Assist the Centers for Medicare and Medicaid Services (CMS) with Coverage Decisions - Draft Guidance for Sponsors, Clinical Investigators, Industry, Institutional Review Boards and Food and Drug Administration Staff CDRH CBER 1500074 June 01, 2016
Technical Considerations for Additive Manufactured Devices - Draft Guidance for Industry and Food and Drug Administration Staff CDRH CBER 1400002 May 10, 2016
Emergency Use Authorization of Medical Products and Related Authorities ProceduralGuidance - Emergency Use Authorization of Medical Products April 01, 2016
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Investigational Device Exemptions (IDEs) for Neurological Devices Targeting Disease Progression and Clinical Outcomes - Draft Guidance for Industry and Food and Drug Administration Staff OSEL ODE/DNPMD/NDB 1500021 March 07, 2016
Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization - Draft Guidance for Industry and Food and Drug Administration Staff ODE OSB 1500051 March 04, 2016
Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices - Draft Guidance for Industry and Food and Drug Administration Staff ODE/DOD 1300006 February 12, 2016
Display Devices for Diagnostic Radiology - Draft Guidance for Industry and Food and Drug Administration Staff OIR/DRH OSEL/DIDSR 1500022 February 09, 2016
List of Highest Priority Devices for Human Factors Review - Draft Guidance for Industry and Food and Drug Administration Staff ODE 1500052 February 03, 2016
Enforcement Policy on National Health Related Item Code and National Drug Code Numbers Assigned to Devices - Draft Guidance for Industry and Food and Drug Administration Staff CDRH CBER 1500044 February 03, 2016
Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices - Draft Guidance for Industry and Food and Drug Administration Staff CDRH CBER 1500015 January 26, 2016
Postmarket Management of Cybersecurity in Medical Devices - Draft Guidance for Industry and Food and Drug Administration Staff CDRH CBER 1400044 January 22, 2016
Unique Device Identification: Convenience Kits - Draft Guidance for Industry and Food and Drug Administration Staff CDRH CBER 1500010 January 04, 2016
Public Notification of Emerging Postmarket Medical Device Signals ("Emerging Signals") - Draft Guidance for Industry and Food and Drug Administration Staff OCE OSB 1500027 December 31, 2015
Electroconvulsive Therapy (ECT) Devices for Class II Intended Uses - Draft Guidance for Industry, Clinicians and Food and Drug Administration Staff ODE/DNPMD 1823 December 29, 2015
Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices - Draft Guidance for Industry and Food and Drug Administration Staff OSEL/DBP ODE OIR 1400057 November 02, 2015
Manufacturing Site Change Supplements: Content and Submission - Draft Guidance for Industry and Food and Drug Administration Staff CDRH/OC CBER 1269 October 21, 2015
General Considerations for Animal Studies for Medical Devices - Draft Guidance for Industry and Food and Drug Administration Staff ODE OC 1802 October 14, 2015
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 OIR/DMD 1740 August 14, 2015
Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices - Draft Guidance for Industry and Food and Drug Administration Staff OIR/DRH OSEL/DP 340 July 14, 2015
Heparin-Containing Medical Devices and Combination Products: Recommendations for Labeling and Safety Testing - Draft Guidance for Industry and Food and Drug Administration Staff ODE 1817 July 09, 2015
Unique Device Identification: Direct Marking of Devices - Draft Guidance for Industry and Food and Drug Administration Staff CDRH CBER 1400031 June 26, 2015
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 CDRH CBER 1500017 June 18, 2015
Adaptive Designs for Medical Device Clinical Studies - Draft Guidance for Industry and Food and Drug Administration Staff CDRH CBER 1500005 May 18, 2015

Page Last Updated: 01/20/2015
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