Medical Devices

Office of Device Evaluation Final Guidance 1998 - 2009

This page lists final guidance documents developed by CDRH’s Office of Device Evaluation, 1998 - 2009. For a list of current draft guidance documents, please see the Draft Guidance page.

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ODE Final Guidance Documents 2008 - 2009

TitleOrganizationDoc #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
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
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
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
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
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
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
Medical Glove Guidance Manual - Guidance for Industry and FDA Staff (PDF - 738KB) ODE/DAGRID 1661 01/22/08

ODE Final Guidance Documents 2006 - 2007

TitleOrganizationDoc #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
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
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
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 - Class II Special Controls Guidance Document: Olfactory Test Device ODE/DOED/ENTB 1595 06/07/06
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

ODE Final Guidance Documents 2004 - 2005

TitleOrganizationDoc #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
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
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 - 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

ODE Final Guidance Documents 2002 - 2003

TitleOrganizationDoc #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
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
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
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

ODE Final Guidance Documents 2000 - 2001

TitleOrganizationDoc #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
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
Final Guidance for Industry and FDA Reviewers: Class II Special Controls Guidance for Home Uterine Activity Monitors 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
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 Issues 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 (PDF - 2.1MB) 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 (PDF - 1.6MB) 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

ODE Final Guidance Documents 1998 - 1999

TitleOrganizationDoc #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 (PDF - 1.8MB) ODE 585 09/09/99
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) (PDF - 1.1MB) 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: 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
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) (PDF - 146KB) ODE/DOED/ENTB 930 01/14/98

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