Medical Devices

Recent Final Medical Device Guidance Documents

This list contains the 25 most recent final medical device guidance documents. For a complete listing, please see the Guidance Documents homepage.

Recent Final Guidance

Title Organization Doc # Date
Emergency Use Authorization of Medical Products and Related Authorities ProceduralGuidance - Emergency Use Authorization of Medical Products January 13, 2017
Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions - Guidance for Investigational Device Exemption Sponsors, Sponsor-Investigators and Food and Drug Administration Staff CDRH CBER 1783 January 13, 2017
Current Good Manufacturing Practice Requirements for Combination Products Guidance for Industry and FDA Staff: Current Good Manufacturing Practice Requirements for Combination Products January 10, 2017
Current Good Manufacturing Practice Requirements for Combination Products: Guidance for Industry and FDA Staff Guidance for Industry and FDA Staff: Current Good Manufacturing Practice Requirements for Combination Products January 10, 2017
Medical Device Accessories - Describing Accessories and Classification Pathway for New Accessory Types - Guidance for Industry and Food and Drug Administration Staff CDRH CBER 1770 December 30, 2016
Postmarket Management of Cybersecurity in Medical Devices - Guidance for Industry and Food and Drug Administration Staff CDRH CBER 1400044 December 28, 2016
Public Notification of Emerging Postmarket Medical Device Signals ("Emerging Signals") - Guidance for Industry and Food and Drug Administration Staff OCD 1500027 December 14, 2016
Immediately in Effect Guidance Document: Conditions for Sale for Air-Conduction Hearing Aids - Guidance for Industry and Food and Drug Administration Staff ODE/DOED 16041 December 12, 2016
Mitigating the Risk of Cross-Contamination from Valves and Accessories Used for Irrigation Through Flexible Gastrointestinal Endoscopes - Guidance for Industry and Food and Drug Administration Staff ODE 1400054 November 29, 2016
Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices - Guidance for Industry and Food and Drug Administration Staff OIR/DRH OSEL/DP 340 November 18, 2016
Medical Device Reporting for Manufacturers - Guidance for Industry and Food and Drug Administration Staff OSB/DPS 1828 November 08, 2016
Clinical Considerations for Investigational Device Exemptions (IDEs) for Neurological Devices Targeting Disease Progression and Clinical Outcomes - Guidance for Industry and Food and Drug Administration Staff OSEL ODE/DNPMD/NDB 1500021 November 07, 2016
Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization - Guidance for Industry and Food and Drug Administration Staff ODE OSB 1500051 October 31, 2016
Collection of Race and Ethnicity Data in Clinical Trials - Guidance for Industry and FDA Staff Guidance for Industry and FDA Staff - Collection of Race and Ethnicity Data in Clinical Trials (PDF) October 26, 2016
Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use - Guidance for Industry and Food and Drug Administration Staff OIR/DCTD 1755 October 11, 2016
Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use - Guidance for Industry and Food and Drug Administration Staff OIR/DCTD 1756 October 11, 2016
Reporting of Computational Modeling Studies in Medical Device Submissions - Guidance for Industry and Food and Drug Administration Staff ODE OSEL 1807 September 21, 2016
Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices - Guidance for Industry and Food and Drug Administration Staff OIR/DRH 644 September 01, 2016
Enforcement Policy on National Health Related Item Code and National Drug Code Numbers Assigned to Devices - Guidance for Industry and Food and Drug Administration Staff CDRH CBER 1500044 August 30, 2016
Guidance for Industry and Food and Drug Administration Staff - Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications CDRH CBER 1772 August 24, 2016
Patient Preference Information - Voluntary Submission, Review in Premarket Approval Applications, Humanitarian Device Exemption Applications, and De Novo Requests, and Inclusion in Decision Summaries and Device Labeling - Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders CDRH CBER 1500006 August 24, 2016
FY 2017 Medical Device User Fee Small Business Qualification and Certification - Guidance for Industry, Food and Drug Administration Staff and Foreign Governments CBER CDRH 2016 August 01, 2016
General Wellness: Policy for Low Risk Devices - Guidance for Industry and Food and Drug Administration Staff OCD 1300013 July 29, 2016
Adaptive Designs for Medical Device Clinical Studies - Guidance for Industry and Food and Drug Administration Staff CDRH CBER 1500005 July 27, 2016
Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices - Guidance for Industry and Food and Drug Administration Staff OSEL/DBP ODE OIR 1400057 July 11, 2016

Page Last Updated: 03/12/2015
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