Medical Devices

Office of Device Evaluation Final Guidance 2010 - 2015

This page lists final guidance documents developed by CDRH’s Office of Device Evaluation, 2010 - 2015. For a list of current draft guidance documents, please see the Draft Guidance page.

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ODE Final Guidance Documents 2010 - 2014

TitleOrganizationDoc #Date
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 (PDF - 410KB) ODE/DCD OSEL 1826 08/18/15
Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices - Guidance for Industry and Food and Drug Administration Staff (PDF - 419KB) ODE/DOENTD 1836 08/17/15
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 (PDF - 303KB) ODE 1300046 08/14/15
Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling - Guidance for Industry and Food and Drug Administration Staff (PDF - 1.3MB) CDRH/ODE CBER 1748 03/17/15
Safety Considerations to Mitigate the Risks of Misconnections with Small-bore Connectors Intended for Enteral Applications - Guidance for Industry and Food and Drug Administration Staff (PDF - 136KB) ODE/DRGUD/GDB 1784 02/11/15
Infusion Pumps Total Product Life Cycle - Guidance for Industry and FDA Staff (PDF - 604KB) ODE/DAGHRICDD/GHDB 1694 12/02/14
Immediately in Effect Guidance Document: Product Labeling for Laparoscopic Power Morcellators - Guidance for Industry and Food and Drug Administration Staff (PDF - 2.2MB) ODE/DRGUD/DSD 1400052 11/25/14
Content of Premarket Submissions for Management of Cybersecurity in Medical Devices - Guidance for Industry and Food and Drug Administration Staff (PDF - 324KB) CDRH/ODE CDRH/OIR CBER 1825 10/02/14
Custom Device Exemption - Guidance for Industry and Food and Drug Administration Staff (PDF - 549KB) CDRH/ODE CDRH/OC 1820 09/24/14
Guideline for Industry and Food and Drug Administration Staff - Class II Special Controls Guideline: Temporary Mandibular Condyle Reconstruction Plate ODE 1799 12/30/13
Guidance for Industry and FDA Staff - Investigational Device Exemption (IDE) Guidance for Retinal Prostheses OSEL ODE 1809 03/06/13
Pulse Oximeters - Premarket Notification Submissions [510(k)s]: Guidance for Industry and Food and Drug Administration Staff ODE/DGAICDD/ARDB 1605 03/04/13
Clinical Study Designs for Surgical Ablation Devices for Treatment of Atrial Fibrillation - Guidance for Industry and Food and Drug Administration Staff ODE/DCD/CEMB 1708 02/15/13
Guidance for Industry and Food and Drug Administration Staff - The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for Artificial Pancreas Device Systems (PDF - 847KB) CDRH 1759 11/09/12
Guidance for Industry and Food and Drug Administration Staff - FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act CDRH CBER 1671 04/06/12
Guidance for Industry and Food and Drug Administration Staff - User Fees for 513(g) Requests for Information CDRH CBER 1709 04/06/12
Guidance for Industry and FDA Staff - Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications (PDF - 827KB) ODE OIVD 1772 03/29/12
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation (rTMS) Systems ODE 1728 07/26/11
Guidance for Industry and Food and Drug Administration Staff - Class II Special Controls Guidance Document: Electrocardiograph Electrodes ODE/DCD/CEMB 1597 07/21/11
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Focused Ultrasound Stimulator System for Aesthetic Use ODE/DSORD 1701 07/20/11
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Topical Oxygen Chamber for Extremities ODE/DSORD/PRSDB 1582 04/25/11
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use ODE/DSORD/GSDB 1735 04/14/11
Guidance for Industry and FDA Staff - Clinical Investigations of Devices Indicated for the Treatment of Urinary Incontinence ODE/DRARD/ULDB 1636 03/08/11
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Contact Cooling System for Aesthetic Use ODE/DSORD 1734 02/07/11
Guidance for Industry and Food and Drug Administration Staff - Blood Lancet Labeling ODE/DSORD 1732 11/29/10
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Non-powered Suction Apparatus Device Intended for Negative Pressure Wound Therapy (NPWT) ODE/DSORD/PRSDB 1702 11/10/10
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Tissue Adhesive with Adjunct Wound Closure Device Intended for the Topical Approximation of Skin ODE/DSORD/PRSDB 1683 11/10/10
Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters ODE/DCD/ICDB 1608 09/08/10
Guidance for Industry and Food and Drug Administration Staff - Guidance for the Non‐Clinical and Clinical Investigation of Devices Used for the Treatment of Benign Prostatic Hyperplasia (BPH) (PDF - 442KB) ODE/DRARD/ULDB 1724 08/17/10
Guidance for Industry and Food and Drug Administration Staff - Contact Lens Care Products Labeling ODE/DOENTD/ICNDB 1725 08/15/10
Guidance for Industry and FDA Staff - Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems ODE/DCD/PVDB ODE/DCD/ICDB 1545 04/18/10
Guidance for Industry and FDA Staff: General Considerations for Animal Studies for Cardiovascular Devices ODE/DCD 1717 07/29/10

Page Last Updated: 08/17/2015
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