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
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
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
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
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
Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices - Guidance for Industry and Food and Drug Administration Staff CDRH CBER 1827 June 21, 2016
Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" - Guidance for Industry and Food and Drug Administration Staff ODE 1811 June 16, 2016
Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act - Guidance for Industry and Food and Drug Administration Staff OSB/DE 1754 May 16, 2016
Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices - Guidance for Industry and Food and Drug Administration Staff OIR/DMGP/MPCB, OSEL 1400053 April 20, 2016
Radiation Biodosimetry Medical Countermeasure Devices - Guidance for Industry and Food and Drug Administration Staff OIR/DMGPD 1400045 April 18, 2016
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 OSEL/DBP 1500001 March 22, 2016
Medical Devices and Clinical Trial Design for the Treatment or Improvement in the Appearance of Fungally-Infected Nails - Guidance for Industry and Food and Drug Administration Staff ODE/DSD 1400009 March 07, 2016

Page Last Updated: 03/12/2015
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