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
General Wellness: Policy for Low Risk Devices - Guidance for Industry and Food and Drug Administration Staff OCD 1300013 July 29, 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
Recommendations for Premarket Notifications for Lamotrigine and Zonisamide Assays - Guidance for Industry and Food and Drug Administration Staff OIR/DCTD 1654 February 09, 2016
Applying Human Factors and Usability Engineering to Medical Devices - Guidance for Industry and Food and Drug Administration Staff ODE 1757 February 03, 2016
Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile - Guidance for Industry and Food and Drug Administration Staff CBER CDRH/ODE 1615 January 21, 2016
Premarket Studies of Implantable Minimally Invasive Glaucoma Surgical (MIGS) Devices - Guidance for Industry and Food and Drug Administration Staff ODE/DOENTD/ICIB 1400049 December 15, 2015
Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings - Guidance for Industry and Food and Drug Administration Staff ODE/DAGHRICDD 1500025 December 09, 2015
eCopy Program for Medical Device Submissions - Guidance for Industry and Food and Drug Administration Staff CDRH CBER 1797 December 03, 2015
Class II Special Controls Guideline: Gastrointestinal Microorganism Multiplex Nucleic Acid-Based Assays for Detection and Identification of Microorganisms and Toxin Genes from Human Stool Specimens - Guideline for Industry and Food and Drug Administration Staff OIR/DMD 1500014 November 02, 2015
Class II Special Controls Guideline Document: Toxin Gene Amplification Assays for the Detection of Clostridium difficile - Guideline for Industry and Food and Drug Administration Staff OIR/DMD 120022 August 27, 2015
Select Updates for Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems - Guidance for Industry and Food and Drug Administration Staff ODE/DCD OSEL 1826 August 18, 2015
Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices - Guidance for Industry and Food and Drug Administration Staff ODE/DOENTD 1836 August 17, 2015
Intent to Exempt Certain Unclassified, Class II, and Class I Reserved Medical Devices from Premarket Notification Requirements - Guidance for Industry and Food and Drug Administration Staff ODE 1300046 August 14, 2015
Global Unique Device Identification Database (GUDID): Data Submission Compliance Date of September 24, 2015 - Guidance for Industry and Food and Drug Administration Staff CDRH CBER 1500036 August 14, 2015
Refuse to Accept Policy for 510(k)s - Guidance for Industry and Food and Drug Administration Staff CDRH CBER 1793 August 04, 2015
Class II Special Controls Guideline: Nucleic Acid Amplification Assays for the Detection of Trichomonas vaginalis - Guideline for Industry and Food and Drug Administration Staff CDRH/OIR 1100491 August 04, 2015
FY 2016 Medical Device User Fee Small Business Qualification and Certification - Guidance for Industry, Food and Drug Administration Staff and Foreign Governments CBER CDRH 2016 August 03, 2015
Content and Format for Abbreviated 510(k)s for Early Growth Response 1 (EGR1) Gene Fluorescence In-Situ Hybridization (FISH) Test System for Specimen Characterization Devices - Guidance for Industry and Food and Drug Administration Staff OIR/DMGP/MGB 1400030 June 17, 2015

Page Last Updated: 03/12/2015
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