ODE Guidance Documents 2010 - 2011

Title	Organization	Doc #	Date
Draft Guidance for Industry and Food and Drug Administration Staff - eCopy Program for Medical Device Submissions (PDF - 498KB)	CDRH	1797	10/17/12
Draft Guidance for Industry and Food and Drug Administration Staff - Safety Considerations for 510(k) Submissions to Mitigate the Risks of Misconnections with Small-bore Connectors Intended for Enteral Applications	ODE/DRGURD	1784	07/27/12
Draft Guidance for Industry and Food and Drug Administration Staff - Class II Special Controls Guidance Document: Implanted Blood Access Devices for Hemodialysis	ODE/DRGRUD	1781	06/20/12
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
Draft Guidance for Industry and Food and Drug Administration Staff - The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]	CDRH/ODE CBER	1766	12/27/11
Draft Guidance for Industry and Food and Drug Administration Staff - The Content of Investigational Device Exemption (IDE) and Premarket Applications for Artificial Pancreas Device Systems	ODE	1786	12/06/11
Draft Guidance for Industry and Food and Drug Administration Staff - Investigational Device Exemptions (IDE) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies	ODE OIVD	1782	11/10/11
Draft Guidance for Industry and Food and Drug Administration Staff - Class II Special Controls Guidance Document: External Pacemaker Pulse Generator	ODE/DCD	1769	10/17/11
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
Draft Guidance for Industry and Food and Drug Administration Staff - Applying Human Factors and Usability Engineering to Optimize Medical Device Design	ODE	1757	06/22/11
Draft Guidance for Industry and Food and Drug Administration Staff - The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for Low Glucose Suspend (LGS) Device Systems	CDRH/ODE	1759	06/22/11
Draft Guidance for Industry and FDA Staff - Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling	CDRH/ODE CBER	1644	05/02/11
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
Draft Guidance for Industry and FDA Staff - Recommended Warning for Surgeon's Gloves and Patient Examination Gloves that Use Powder	OSEL ODE/DAGID	1704	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
Draft Guidance for Industry and FDA Staff: Heart Valves - Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications	ODE/DCD/CSPDB	1607	01/20/10
Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Transcutaneous Electrical Nerve Stimulator with Limited Output for Pain Relief	ODE/DRARD/ULDB	1574	04/05/10
Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Transcutaneous Electrical Nerve Stimulator for Pain Relief Intended	ODE/DRARD/ULDB	1670	04/05/10
Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Powered Muscle Stimulator with Limited Output for Muscle Conditioning	ODE/DRARD/ULDB	1580	04/05/10
Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Powered Muscle Stimulator for Rehabilitation	ODE/DRARD/ULDB	1577	04/05/10
Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Powered Muscle Stimulator with Limited Output for Rehabilitation	ODE/DRARD/ULDB	1578	04/05/10
Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Transcutaneous Electrical Stimulator for Aesthetic Purposes	ODE/DRARD/ULDB	1575	04/05/10
Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Transcutaneous Electrical Stimulator with Limited Output for Aesthetic Purposes	ODE/DRARD/ULDB	1576	04/05/10
Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Powered Muscle Stimulator for Muscle Conditioning	ODE/DRARD/ULDB	1579	04/05/10
Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Cutaneous Electrode	ODE/DRARD/ULDB	1572	04/05/10
Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Electroconductive Media	ODE/DRARD/ULDB	1571	04/05/10
Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Transcutaneous Electrical Nerve Stimulator for Pain Relief	ODE/DRARD/ULDB	1573	04/05/10
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 - Total Product Life Cycle: Infusion Pump - Premarket Notification [510(k)] Submissions	ODE/DAGID/GHDB	1694	04/23/10
Guidance for Industry and FDA Staff: General Considerations for Animal Studies for Cardiovascular Devices	ODE/DCD	1717	07/29/10