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 For a complete listing, please see the Draft Guidance page.

Recent Draft Guidance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
Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices - Draft Guidance for Industry and Food and Drug Administration Staff CDRH CDER 1400061 September 21, 2016
510(k) Third Party Review Program - Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations OIR ODE 1500013 September 12, 2016
Deciding When to Submit a 510(k) for a Change to an Existing Device - Draft Guidance for Industry and Food and Drug Administration Staff CDRH CBER 1500054 August 08, 2016
Deciding When to Submit a 510(k) for a Software Change to an Existing Device - Draft Guidance for Industry and Food and Drug Administration Staff CDRH CBER 1500055 August 08, 2016
Medical X-Ray Imaging Devices Conformance with IEC Standards - Draft Guidance for Industry and Food and Drug Administration Staff OIR/DRH OSEL/DIDSR 1400014 August 03, 2016
Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices - Draft Guidance for Industry and Food and Drug Administration Staff CDRH CBER 1500012 July 27, 2016
Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI) - Draft Guidance for Industry and Food and Drug Administration Staff CDRH CBER 1500035 July 26, 2016
Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product - Draft Guidance for Industry and Food and Drug Administration Staff CDRH CDER CBER 1400027 July 15, 2016
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Oversight of Next Generation Sequencing (NGS)-Based In Vitro Diagnostics (IVDs) Used for Diagnosing Germline Diseases - Draft Guidance for Stakeholders and Food and Drug Administration Staff CDRH/OIR CBER 16009 July 08, 2016
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Variant Databases to Support Clinical Validity for Next Generation Sequencing (NGS)-Based In Vitro Diagnostics - Draft Guidance for Stakeholders and Food and Drug Administration Staff CDRH/OIR CBER 16008 July 08, 2016
Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies - Draft Guidance for Industry and Food and Drug Administration Staff CDRH CBER 1500626 June 20, 2016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
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

Page Last Updated: 01/20/2015
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