ODE Guidance

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ODE Guidance Documents 2008 - 2009

Title	Organization	Doc #	Date
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Wound Dressing with Poly(diallyl dimethyl ammonium chloride) (pDADMAC) Additive	ODE/DGRND/PRSDB	1684	10/16/09
Draft Guidance for Industry and FDA Staff - Clinical Study Designs for Surgical Ablation Devices for Treatment of Atrial Fibrillation	ODE/DCD/CEMB	1708	09/14/09
Class II Special Controls Guidance Document: Dental Amalgam, Mercury, and Amalgam Alloy - Guidance for Industry and FDA Staff	ODE/DAGID/DEDB	1192	07/28/09
Draft Guidance for Industry and FDA Staff: Investigational Device Exemption (IDE) Guidance for Retinal Prostheses	ODE/DOED/VEDB	1651	04/17/09
Guidance for Industry and FDA Staff: Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products	ODE/DOED/ENTB	1696	02/25/09
Guidance for Industry: Designation of Special Controls for Male Condoms Made of Natural Rubber Latex (21 CFR 884.5300); Small Entity Compliance Guide	ODE/DRARD/OGDB	1693	01/05/09
Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Tissue Expander	ODE/DGRND/PRSB	1628	12/22/08
Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile	CBER CDRH/ODE	1615	12/12/08
Draft Guidance for Industry and FDA Staff - Clinical Investigations of Devices Indicated for the Treatment of Urinary Incontinence	ODE/DRARD/ULDB	1636	09/19/08
Guidance for Industry and FDA Staff - Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers	OSEL ODE/DRARD	560	09/09/08
Guidance for Industry and FDA Staff: Clinical Study Designs for Catheter Ablation Devices for Treatment of Atrial Flutter	ODE/DCD/CEMB	1678	08/05/08
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Bone Sonometers	OSEL ODE/DRARD	1547	07/17/08
Guidance for Industry and FDA Staff - Intravascular Administration Sets Premarket Notification Submissions [510(k)]	ODE/DAGID/GHDB	1189	07/11/08
Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Tissue Adhesive for the Topical Approximation of Skin	ODE/DGRND/PRSB	1630	05/30/08
Draft Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters	ODE/DCD/ICDB	1608	05/30/08
Guidance for Industry and FDA Staff: Display Accessories for Full-Field Digital Mammography Systems-Premarket Notification (510(k)) Submissions	OSEL ODE/DRARD	1617	05/30/08
Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Full Field Digital Mammography System	OSEL ODE/DRARD	1616	05/30/08
Guidance for Industry and FDA Staff: Hemodialysis Blood Tubing Sets - Premarket Notification [510(k)] Submissions	ODE/DRARD/GRDB	1649	04/23/08
Guidance for Industry and FDA Staff: Investigational Device Exemptions (IDEs) for Devices Indicated for Nocturnal Home Hemodialysis	ODE/DRARD/GRDB	1650	04/15/08
Guidance for Industry and FDA Staff: Preparation and Review of Investigational Device Exemption Applications (IDEs) for Total Artificial Discs	ODE/DGRND/ORDB	1637	04/11/08
Coronary Drug-Eluting Stents-Nonclinical and Clinical Studies
Coronary Drug-Eluting Stents — Nonclinical and Clinical Studies -Companion Document
Guidance for Industry and FDA Staff: Coronary and Carotid Embolic Protection Devices - Premarket Notification [510(k)] Submissions	ODE/DCD/PVDB ODE/DCD/ICDB	1658	02/15/08

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ODE Guidance Documents 2006 - 2007

Title	Organization	Doc #	Date
Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Remote Medication Management System	ODE/DAGID/GHDB	1621	10/19/07
Guidance for Industry and FDA Staff - Biological Indicator (BI) Premarket Notification [510(k)] Submissions	ODE/DGRND/INCB	1320	10/04/07
Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Electrocardiograph Electrodes	ODE/DCD/CEMB	1597	10/04/07
Guidance for Industry and FDA Staff - Non-clinical Information for Femoral Stem Prostheses	ODE/DGRND/ORDB	1647	09/17/07
Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Absorbable Poly(hydroxybutyrate) Surgical Suture Produced by Recombinant DNA Technology	ODE/DGRND/PRSB	1629	08/03/07
Draft Guidance for Industry and FDA Staff - Premarket Notification [510(k)] Submissions for Medical Devices that Include Antimicrobial Agents	ODE	1557	07/19/07
Draft Guidance for Industry and FDA Staff - Pulse Oximeters - Premarket Notification Submissions [510(k)s]	ODE/DAGID/ARDB	1605	07/19/07
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Filtering Facepiece Respirator for Use by the General Public in Public Health Medical Emergencies	ODE/DAGID/INCB	1626	07/03/07
Guidance for Industry and FDA Staff - Pre-Clinical and Clinical Studies for Neurothrombectomy Devices	ODE/DGRND/GSDB	1586	06/18/07
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Intervertebral Body Fusion Device	ODE/DGRND/ORDB	1540	06/12/07
Guidance for Industry and FDA Staff: Dental Handpieces - Premarket Notification [510(k)] Submissions	ODE/DAGID/DEDB	556	05/02/07
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Computerized Labor Monitoring Systems	ODE/DRARD/OGDB	1625	04/24/07
Guidance for Industry and FDA Staff - Saline, Silicone Gel, and Alternative Breast Implants	ODE/DGRND/PRSB	1239	11/17/06
Draft Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Absorbable Hemostatic Device	ODE/DGRND	1558	10/31/06
Guidance for Industry and FDA Staff - Medical Device User Fee and Modernization Act of 2002, Validation Data in Premarket Notification Submissions (510(k)s) for Reprocessed Single-Use Medical Devices	ODE	1216	09/25/06
Guidance for Industry and FDA Staff - Keratome and Replacement Keratome Blades Premarket Notification [510(k)] Submissions	ODE/DOED/DSDB	1604	09/18/06
Guidance for Industry and FDA Staff - Humanitarian Device Exemption (HDE) Regulation: Questions and Answers	ODE/ODEOD/POS	1381	07/18/06
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Olfactory Test Device	ODE/DOED/ENTB	1595	06/07/06
Topical Oxygen Chamber for Extremities - Class II Special Controls Guidance Document - Draft Guidance for Industry and FDA Staff	ODE/DGRND/PRSB	1582	04/06/06
Guidance for Industry and FDA Staff: Tonometers - Premarket Notification [510(k)] Submissions	ODE/DOED/DSDB	1593	03/27/06
Dental Curing Lights - Premarket Notification [510(k)]	OSEL/DPS ODE/DAGID/DEDB	1591	03/27/06
Class II Special Controls Guidance Document: Implantable Intra-Aneurysm Pressure Measurement System - Guidance for Industry and FDA Staff	ODE/DCD/PVDB	1589	02/15/06

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ODE Guidance Documents 2004 - 2005

Title	Organization	Doc #	Date
Guidance for Industry and FDA Staff: A Pilot Program to Evaluate a Proposed Globally Harmonized Alternative for Premarket Procedures	ODE	1347	11/10/05
Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Tinnitus Masker Devices	ODE/DOED/ENTB	1555	11/08/05
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Low Energy Ultrasound Wound Cleaner	ODE/DGRND/PRSB	1302	11/07/05
Guidance for Industry and FDA Staff: Dental Composite Resin Devices - Premarket Notification [510(k)] Submissions	ODE/DAGID/DEDB	642	10/26/05
Draft Guidance for Industry and FDA Staff - Functional Indications for Implantable Cardioverter Defibrillators	ODE OC	1304	10/06/05
Guidance for Industry and FDA Staff - Class II Special Controls Document: Oral Rinse to Reduce the Adhesion of Dental Plaque	ODE/DAGID/DEDB	1559	09/20/05
Guidance for Industry and FDA Staff: Format for Traditional and Abbreviated 510(k)s	OIVD ODE	1567	08/12/05
Guidance for Industry and FDA Staff: Medical Devices with Sharps Injury Prevention Features	ODE/DAGID/GHDB	934	08/09/05
Guidance for Industry and FDA Staff - Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s)	ODE/DRARD/OGDB	166	07/27/05
Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices	CBER CDRH/ODE CDRH/OIVD	337	05/11/05
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices	ODE/DAGID/DEDB	1512	04/28/05
Guidance for Industry - Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software	ODE OC	1553	01/14/05
Guidance for Industry and FDA Staff: Non-Clinical Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems	ODE/DCD/PVDB ODE/DCD/ICDB	1545	01/13/05
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices	ODE/DRARD/OGDB ODE/DGRND/PRSB ODE/DCD/PVDB	1234	12/29/04
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Assisted Reproduction Laser Systems	ODE/DRARD/OGDB	1539	12/28/04
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: External Penile Rigidity Devices	ODE/DRARD/ULDB	1231	12/28/04
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Implantable Radiofrequency Transponder System for Patient Identification and Health Information	ODE/DAGID/GHDB	1541	12/10/04
Guidance for Industry and FDA Staff: Clinical Data Presentations for Orthopedic Device Applications	ODE/DGRND/ORDB	1542	12/02/04
Guidance for Industry and FDA Staff - Frequently Asked Questions (FAQs) on the Status of Reprocessed Single Use Devices (SUDs) that receive a Not Substantially Equivalent (NSE) Letter	ODE	1544	11/08/04
Guidance for Industry and FDA Staff - Clinical Trial Considerations: Vertebral Augmentation Devices to Treat Spinal Insufficiency Fractures	ODE/DGRND/REDB ODE/DGRND/ORDB	1543	10/24/04
Guidance for Third Parties and FDA Staff; Third Party Review of Premarket Notifications	OIVD ODE	2237	09/28/04
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Dental Noble Metal Alloys	ODE/DAGID/DEDB	1415	08/23/04
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Dental Base Metal Alloys	ODE/DAGID/DEDB	1416	08/23/04
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments	ODE/DAGID/DEDB	1389	05/12/04
Guidance for Industry and FDA Staff: Spinal System 510(k)s	ODE/DGRND/ORDB	636	05/03/04
Guidance for Industry and FDA Staff: Premarket Approval Applications (PMA) for Absorbable Powder for Lubricating a Surgeon’s Glove	ODE/DAGID/INCB	1230	04/13/04
Guidance for Industry and FDA Staff: Surgical Masks - Premarket Notification [510(k)] Submissions; Guidance for Industry and FDA	ODE/DAGID/INCB	94	03/05/04
Guidance for Industry and FDA Staff: Vocal Fold Medialization Devices - Premarket Notification [510(k)] Submissions	ODE/DOED/ENTB	1535	02/13/04
Guidance for Industry and FDA Staff: Clinical Study Designs for Percutaneous Catheter Ablation for Treatment of Atrial Fibrillation	ODE/DCD/CEMB	1229	01/09/04

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ODE Guidance Documents 2002 - 2003

Title	Organization	Doc #	Date
Premarket Notification [510(k)] Submissions for Chemical Indicators: Guidance for Industry and FDA Staff	ODE/DAGID/INCB	1420	12/19/03
Class II Special Controls Guidance Document: Human Dura Mater; Guidance for Industry and FDA	ODE/DGRND/PRSB	54	12/18/03
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Dental Sonography and Jaw Tracking Devices	ODE/DAGID/DEDB	1393	12/02/03
Premarket Approval Application Modular Review	CBER CDRH/ODE	835	11/03/03
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm	ODE/DCD/CEMB	1363	10/28/03
Guidance for Industry and FDA Staff: Implantable Middle Ear Hearing Device	ODE/DOED/ENTB	1406	08/01/03
Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Breast Lesion Documentation System	ODE/DRARD/OGDB	1202	07/28/03
Guidance for Industry and FDA Staff: Coronary and Peripheral Arterial Diagnostic Catheters	ODE/DCD/CEMB	1228	07/15/03
Guidance for Industry and FDA Staff: Criteria for Significant Risk Investigations of Magnetic Resonance Diagnostic Devices	ODE/DRARD	793	07/14/03
Pediatric Expertise for Advisory Panels; Guidance for Industry and FDA Staff	ODE	1208	06/03/03
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Surgical Sutures	ODE/DGRND/PRSB	1387	06/03/03
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device	ODE/DGRND/REDB	855	06/02/03
Premarket Approval Application Filing Review	CBER CDRH/ODE CDRH/OIVD	297	05/01/03
Class II Special Controls Guidance Document: Optical Impression Systems for Computer Assisted Design and Manufacturing (CAD/CAM) of Dental Restorations; Guidance for Industry and FDA	ODE/DAGID	1203	04/22/03
Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA	ODE/DGRND/ORDB	1418	01/16/03
Class II Special Controls Guidance Document: Cutaneous Carbon Dioxide (PcCO2) and Oxygen (PcO2) Monitors; Guidance for Industry and FDA	ODE/DAGID/ARDB	1335	12/13/02
Determination of Intended Use for 510(k) Devices; Guidance for CDRH Staff (Update to K98-1)	OIVD ODE	857	12/03/02
Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA	ODE/DAGID/DEDB	1378	11/12/02
Class II Special Controls Guidance Document: Transcutaneous Air Conduction Hearing Aid System (TACHAS); Guidance for Industry and FDA	ODE/DOED/ENTB	1414	11/07/02
The Least Burdensome Provisions of the FDA Modernization Act of 1997: Concept and Principles; Final Guidance for FDA and Industry	CBER CDRH/ODE	1332	10/04/02
Updated 510(k) Sterility Review Guidance K90-1; Final Guidance for Industry and FDA	ODE	361	08/30/02
Regulatory Status of Disinfectants Used to Process Dialysate Delivery Systems and Water Purification Systems for Hemodialysis; Guidance for Industry and FDA	ODE/DAGID/INCB	1419	08/30/02
Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement; Guidance for Industry and FDA	ODE/DGRND/ORDB	668	07/17/02
Class II Special Controls Guidance Document: Apnea Monitors; Guidance for Industry and FDA	ODE/DAGID	1178	07/17/02
Cardiac Ablation Catheters Generic Arrhythmia Indications for Use; Guidance for Industry	ODE/DCD/CEMB	1382	07/01/02
Guidance for Resorbable Adhesion Barrier Devices for Use in Abdominal and/or Pelvic Surgery; Guidance for Industry	ODE/DGRND/PRSB ODE/DRARD/OGDB	1356	06/18/02
Class II Special Controls Guidance Document: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis; Guidance for Industry and FDA	ODE/DGRND/ORDB	1328	04/30/02
Class II Special Controls Guidance Document: Endolymphatic Shunt Tube with Valve; Guidance for Industry and FDA	ODE/DOED/ENTB	791	04/29/02
Premarket Notification [510(k)] Submissions for Medical Sterilization Packaging Systems in Health Care Facilities; Draft Guidance for Industry and FDA	ODE/DAGID/INCB	1388	03/07/02
Class II Special Controls Guidance Document: Medical Washers and Medical Washer-Disinfectors; Guidance for the Medical Device Industry and FDA Review Staff	ODE/DAGID/INCB	1252	02/07/02

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ODE Guidance Documents 2000 - 2001

Title	Organization	Doc #	Date
Class II Special Controls Guidance Document: Ingestible Telemetric Gastrointestinal Capsule Imaging System; Final Guidance for Industry and FDA	ODE/DRARD/GRDB	1385	11/28/01
Class II Special Controls Guidance Document: Indwelling Blood Gas Analyzers; Final Guidance for Industry and FDA	ODE/DAGID/ARDB	1126	10/05/01
Availability of Information Given to Advisory Committee Members in Connection with CDRH Open Public Panel Meetings; Draft Guidance for Industry and FDA Staff	ODE	1341	07/18/01
Information for Keratome Manufacturers Regarding LASIK; Final Guidance for Industry	ODE/DOED/DSDB	1376	06/21/01
Changes or Modifications During the Conduct of a Clinical Investigation; Final Guidance for Industry and CDRH Staff	ODE	1337	05/29/01
Class II Special Controls Guidance Document: Tissue Culture Media for Human ex vivo Tissue and Cell Culture Processing Applications; Final Guidance for Industry and FDA Reviewers	ODE/DRARD/GRDB	1325	05/16/01
Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA	ODE/DAGID/GHDB	1326	03/12/01
Class II Special Controls Guidance for Home Uterine Activity Monitors; Final Guidance for Industry and FDA Reviewers (PDF Version Only)	ODE/DRARD/OGDB	820	03/09/01
Premarket Approval Applications (PMA) for Sharps Needle Destruction Devices; Final Guidance for Industry and FDA	ODE/DAGID/INCB	891	03/02/01
Early Collaboration Meetings Under the FDA Modernization Act (FDAMA); Final Guidance for Industry and for CDRH Staff	ODE	310	02/28/01
Premarket Applications for Digital Mammography Systems; Final Guidance for Industry and FDA	ODE/DRARD	983	02/16/01
Guidance for Annuloplasty Rings 510(k) Submissions; Final Guidance for Industry and FDA Staff	ODE/DCD/CSPB	1358	01/31/01
Guidance for Industry and FDA Reviewers: Content of Investigational Device Exemptions for Solutions for Hypothermic Flushing, Transport and Storage of Organs for Transplantation	ODE/DRARD/GRDB	1164	01/16/01
Deciding When To Submit A 510(k) For A Change To An Existing Wireless Telemetry Medical Device: Final Guidance for FDA Reviewers and Industry	ODE	1073	11/30/00
Guidance for Cardiopulmonary Bypass Arterial Line Blood Filter 510(k) Submissions; Final Guidance for Industry and FDA	ODE/DCD/CSPB	1622	11/29/00
Final Guidance for Industry and FDA: Guidance for Extracorporeal Blood Circuit Defoamer - 510(k) Submissions	ODE/DCD/CSPB	1632	11/29/00
Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions; Final Guidance for Industry and FDA Staff	ODE/DCD/CSPB	1361	11/13/00
Guidance Document for Dura Substitute Devices; Guidance for Industry	ODE/DGRND/PRSB	1152	11/09/00
Investigational Device Exemption (IDE) Study Enrollment for Cardiac Ablation of Typical Atrial Flutter; Final Guidance for Industry and FDA Reviewers	ODE/DCD/CEMB	1199	11/08/00
Suggested Format for Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions of FDAMA; Final Guidance for Industry and FDA Staff	ODE	1195	11/02/00
Guidance for Industry and FDA Staff: Guidance Document for Vascular Prostheses 510(k) Submissions	ODE/DCD/PVDB	1357	11/01/00
Guidance for Industry: Guidance for the Submission of Research and Marketing Applications for Permanent Pacemaker Leads and for Pacemaker Lead Adaptor 510(k) Submissions	ODE/DCD/PDLB	372	11/01/00
Guidance for Industry and FDA Staff - Class II Special Controls Guidance: Shoulder Joint Metal/Polymer/Metal Nonconstrained or Semi-Constrained Porous-Coated Uncemented Prosthesis	ODE/DGRND/ORDB	1193	10/31/00
Guidance for Industry: A Suggested Approach to Resolving Least Burdensome	ODE	1188	09/11/00
Guidance for Industry and for FDA Reviewers: Guidance on Section 216 of the Food and Drug Administration Modernization Act of 1997	ODE	1135	08/09/00
Guidance for Industry and for FDA Reviewers: Guidance for the Content of Premarket Notifications (510(k)s) for Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi	ODE/DRARD/ULDB	1226	08/09/00
Guidance for Industry: Guidance for the Submission of Premarket Notifications for Photon-Emitting Brachytherapy Sources	ODE/DRARD	1177	08/02/00
Guidance for Industry: Guidance for the Submission Of Premarket Notifications for Medical Image Management Devices	ODE/DRARD	416	07/27/00
Guidance for Industry and FDA Staff: Guidance on Amended Procedures for Advisory Panel Meetings	ODE	413	07/22/00
Guidance for Industry and CDRH Reviewers: 1-Consolidated Annual Report for a Device product line (1-CARD)	ODE/DCD/PDLB	1167	07/06/00
Guidance for Industry and FDA Reviewers - Class II Special Controls Guidance Document for Clitoral Engorgement Devices	ODE/DRARD/OGDB	1144	07/03/00
Guidance for Industry and FDA Reviewers: Class II Special Control Guidance Document for Acute Upper Airway Obstruction Devices	ODE/DAGID/ARDB	1138	07/03/00
Guidance for Industry: Guidance for Premarket Submissions of Orthokeratology Rigid Gas Permeable Contact Lenses	ODE/DOED/VEDB	1134	04/10/00
Guidance for Manufacturers Seeking Marketing Clearance of Ear, Nose, and Throat Endoscope Sheaths Used as Protective Barriers: Guidance for Industry	ODE/DOED/ENTB	954	03/12/00
Guidance for Industry and for FDA Staff: Use of Standards in Substantial Equivalence Determinations	ODE	1131	03/12/00
Guidance for Industry and FDA Reviewers - Reprocessing and Reuse of Single-Use Devices	ODE/DAGID	1156	02/08/00
Guidance for Industry and for FDA Reviewers - Guidance Document for Premarket Notification Submissions for Nitric Oxide Delivery Apparatus, Nitric Oxide Analyzer and Nitrogen Dioxide Analyzer	ODE/DAGID/ARDB	1157	01/24/00
Guidance for Industry and for FDA Staff: Guidance for the Content of Premarket Notifications for Penile Rigidity Implants	ODE/DRARD/ULDB	177	01/16/00
Guidance for Industry and/or FDA Staff: Guidance Document for the Preparation of IDEs for Spinal Systems	ODE/DGRND/ORDB	2250	01/13/00
Guidance for Industry and FDA Reviewers: Content and Format of Premarket Notification [510(k)] Submissions for Liquid Chemical Sterilants/High Level Disinfectants	ODE/DAGID/INCB	397	01/03/00

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ODE Guidance Documents 1998 - 1999

Title	Organization	Doc #	Date
Guidance for Industry and FDA Staff: Guidance for Cardiovascular Intravascular Filter 510(k) Submissions	ODE/DCD/PVDB	24	11/26/99
Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices	ODE	585	09/09/99
Guidance for Industry and/or for FDA Reviewers/Staff and/or Compliance: Guidance for the Submission of 510(k)’s for Solid State X-ray Imaging Devices	ODE/DRARD	644	08/06/99
Guidance for Industry, FDA Reviewers/Staff and Compliance - Guidance Document for Powered Muscle Stimulator 510(k)s	ODE/DGRND/REDB	2246	06/09/99
Recommended Clinical Study Design for Ventricular Tachycardia Ablation (PDF Version)	ODE/DCD/CEMB	2244	05/07/99
Guidance for Industry and for FDA Reviewers/Staff - Guidance on 510(k) Submissions for Keratoprostheses	ODE/DOED/ICIB	1351	03/03/99
Guidance for Industry - Guidance for Dermabrasion Devices	ODE/DGRND/PRSB	2248	03/02/99
Guidance for Industry and/or for FDA Reviewers/Staff and/or Compliance - Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh	ODE/DGRND/PRSB	2247	03/02/99
Guidance for Industry and FDA Reviewers/Staff: Premarket Notification [510(k)] Submissions for Testing for Skin Sensitization To Chemicals In Natural Rubber Products	ODE/DAGID/INCB	944	01/13/99
Guidance for Industry - Guidance for the Submission of Premarket Notifications for Emission Computed Tomography Devices and Accessories (SPECT and PET) and Nuclear Tomography Systems	ODE/DRARD	2240	12/03/98
Guidance for Industry: Guidance for the Content of Premarket Notifications for Intracorporeal Lithotripters	ODE/DRARD/ULDB	2235	11/30/98
Guidance for Industry - Guidance for the Submission of Premarket Notifications For Radionuclide Dose Calibrators	ODE/DRARD	2238	11/20/98
Guidance for Industry: Non-Automated Sphygmomanometer (Blood Pressure Cuff) Guidance - Version 1	ODE/DCD/CEMB	2239	11/19/98
Guidance for Industry and for FDA Reviewers/Staff: Aqueous Shunts - 510(k) Submissions	ODE/DOED/ICIB	2236	11/16/98
Guidance for Industry - Harmonic Imaging with/without Contrast - Premarket Notification Requirements	ODE/DRARD	2234	11/16/98
Guidance for FDA Reviewers and Industry Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices)	ODE	2206	11/06/98
Guidance for Industry: Guidance for the Submission Of Premarket Notifications for Magnetic Resonance Diagnostic Devices	ODE/DRARD	340	11/14/98
Guidance for Industry: Cardiac Monitor Guidance (including Cardiotachometer and Rate Alarm)	ODE/DCD/PDLB	2233	11/05/98
Guidance for Industry: Diagnostic ECG Guidance (Including Non-Alarming ST Segment Measurement)	ODE/DCD/PDLB	2232	11/05/98
Guidance for Industry: General/Specific Intended Use	ODE	499	11/04/98
Guidance for Industry: Frequently Asked Questions on the New 510(K) Paradigm	ODE	2230	10/22/98
Guidance for Industry - Noise Claims in Hearing Aid Labeling	ODE/DOED	2210	10/21/98
Guidance for Industry: Guidance Document For Nonprescription Sunglasses	ODE/DOED/DSDB	2208	10/09/98
Guidance for Industry and FDA Reviewers/Staff: Guidance Document for Powered Suction Pump 510(k)s	ODE/DGRND/GSDB	2207	09/30/98
Guidance for Industry and FDA Reviewers/Staff - Neonatal and Neonatal Transport Incubators - Premarket Notifications	ODE/DAGID/GHDB	2201	09/18/98
Guidance for Industry and FDA Staff: Dental Cements - Premarket Notification	ODE/DAGID	2204	08/18/98
Guidance for Industry and FDA Staff - OTC Denture Cushions, Pads, Reliners, Repair Kits, and Partially Fabricated Denture Kits	ODE/DAGID	2205	08/18/98
Guidance for Industry and FDA Staff - Dental Impression Materials Premarket Notification	ODE/DAGID	2203	08/17/98
Guidance for Industry and FDA Staff: Revised Procedures for Adding Lens Finishing Laboratories to Approved Premarket Approval Applications for Class III Rigid Gas Permeable Contact Lenses for Extended Wear	ODE/DOED/VEDB	1249	08/11/98
Guidance for Industry and CDRH Reviewers: Guidance for the Content of Premarket Notifications for Hemodialysis Delivery Systems	ODE/DRARD/GRDB	2202	08/07/98
Guidance for Industry and CDRH Reviewers: Guidance for the Content of Premarket Notifications for Conventional and High Permeability Hemodialyzers	ODE/DRARD/GRDB	421	08/07/98
Guidance for Industry: Latex Condoms for Men - Information for 510(k) Premarket Notifications: Use of Consensus Standards for Abbreviated Submissions	ODE/DRARD/OGDB	1250	07/23/98
Guidance for Industry - Uniform Contraceptive Labeling	ODE/DRARD/OGDB	1251	07/23/98
Guidance for Industry, FDA Reviewers/Staff and Compliance: Guidance Document for Surgical Lamp 510(k)s	ODE/DGRND/GSDB	1244	07/13/98
Guidance for Industry: Ophthalmoscope Guidance - (Direct and Indirect)	ODE/DOED/DSDB	1241	07/08/98
Guidance for Industry: Slit Lamp Guidance	ODE/DOED/DSDB	1242	07/08/98
Guidance for Industry: Retinoscope Guidance	ODE/DOED/DSDB	1240	07/08/98
Guidance Document For Washers And Washer-Disinfectors Intended For Processing Reusable Medical Devices (Text Only)	ODE/DAGID/INCB	4	06/02/98
Guidance for Industry - Supplements to Approved Applications for Class III Medical Devices: Use of Published Literature, Use of Previously Submitted Materials, and Priority Review (Text Only)	ODE	380	05/20/98
Guidance For Industry - Guidance For The Content Of Premarket Notifications For Esophageal And Tracheal Prostheses	ODE/DGRND/PRSB	6	04/28/98
The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications - Final Guidance	ODE	905	03/20/98
Guidance on PMA Interactive Procedures for Day-100 Meetings and Subsequent Deficiencies - for Use by CDRH and Industry	ODE	322	02/19/98
30-Day Notices and 135-Day PMA Supplements for Manufacturing Method or Process Changes, Guidance for Industry and CDRH	ODE	795	02/19/98
New Section 513(f)(2) - Evaluation of Automatic Class III Designation, Guidance for Industry and CDRH Staff	ODE	199	02/19/98
Procedures for Class II Device Exemptions from Premarket Notification, Guidance for Industry and CDRH Staff	ODE	159	02/19/98
Guidance For The Content Of Premarket Notifications For Metal Expandable Biliary Stents	ODE/DRARD/GRDB	2243	02/05/98
Guidance on IDE Policies and Procedures	ODE	882	01/20/98
Tympanostomy Tubes, Submission Guidance for a 510(k) Premarket Notification; Final (PDF only)	ODE/DOED/ENTB	930	01/14/98

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