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
Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses - Guidance for Industry and Food and Drug Administration Staff OIR/DMD 1740 September 15, 2017
Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies - Guidance for Industry and Food and Drug Administration Staff CDRH CBER 1500626 September 12, 2017
Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices - Guidance for Industry and Food and Drug Administration Staff CDRH CBER 1500015 September 06, 2017
Procedures for Meetings of the Medical Devices Advisory Committee - Guidance for Industry and Food and Drug Administration Staff CDRH/ODE CDRH/OIR 413 September 01, 2017
Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices - Guidance for Industry and Food and Drug Administration Staff CDRH CBER 1500012 August 31, 2017
FY 2018 Medical Device User Fee Small Business Qualification and Certification - Guidance for Industry, Food and Drug Administration Staff and Foreign Governments CDRH CBER 2017 August 29, 2017
IRB Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human Subjects Guidance for Sponsors, Investigators, and Institutional Review Boards: IRB Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human Subjects July 13, 2017
Form FDA 3674 - Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions Guidance for Sponsors, Industry, Researchers, Investigators, and Food and Drug Administration Staff - Form FDA 3674 - Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions June 07, 2017
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 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: 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

Page Last Updated: 03/12/2015
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