Medical Devices

Office of Device Evaluation Final Guidance 1976 - 1997

This page lists final guidance documents developed by CDRH’s Office of Device Evaluation, 1976 -1997. For a list of current draft guidance documents, please see the Draft Guidance page.

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ODE Final Guidance Documents 1996 - 1997

TitleOrganizationDoc #Date
Notice to Manufacturers of Bone Mineral Densitometers ODE/DRARD 552 09/25/97
Testing for Sensitizing Chemicals in Natural Rubber Latex Medical Devices (Addendum to 944) (PDF Only) (PDF - 156KB) ODE/DAGID/INCB 1944 07/28/97
ORDB 510(K) Sterility Review Guidance ODE/DGRND/ORDB 659 07/03/97
Kit Certification for 510(k)s (Text Only) ODE 562 07/01/97
Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis ODE/DRARD/GRDB 842 05/30/97
Convenience Kits Interim Regulatory Guidance ODE 562 05/20/97
Premarket Notification 510(k) Guidance for Contact Lens Care Products (PDF Only) (PDF - 360KB) ODE/DOED/VEDB 674 05/01/97
Non-Invasive Blood Pressure (NIBP) Monitor Guidance (Text Only) ODE/DCD/CEMB 123 03/10/97
Reviewers Guidance Checklist For Intramedullary Rods ODE/DGRND/ORDB 956 02/21/97
Reviewers Guidance Checklist For Orthopedic External Fixation Devices Version #5 ODE/DGRND/ORDB 829 02/21/97
510(K) Information Needed for Hydroxyapatite Coated Orthopedic Implants ODE/DGRND/ORDB 47 02/20/97
Electrocardiograph (ECG) Electrode (PDF Only) (PDF - 388KB) ODE/DCD/CEMB 25 02/11/97
Electrocardiograph (ECG) Lead Switching Adapter (PDF Only) (PDF - 295KB) ODE/DCD/CEMB 26 02/11/97
Electrocardiograph (ECG) Surface Electrode Tester (PDF Only) (PDF - 259KB) ODE/DCD/CEMB 27 02/11/97
Guidelines for Reviewing Premarket Notifications that Claim Substantial Equivalence to Evoked Response Stimulators ODE/DGRND/GSDB 593 02/01/97
Third Party Review Guidance For Vitreous Aspiration & Cutting Device Premarket Notification (510(k)) ODE/DOED/DSDB 2196 01/31/97
Third Party Review Guidance for Phacofragmentation System Device Premarket Notification (510(k)) (PDF Only) (PDF - 149KB) ODE/DOED/DSDB 2197 01/31/97
Deciding When to Submit a 510(k) for a Change to an Existing Device (K97-1) ODE 935 01/10/97
Guidance for Submitting Reclassification Petition (PDF Only) (PDF - 1.2MB) ODE 609 01/01/97
Carotid Stent - Suggestions for Content of Submissions to the Food and Drug Administration in Support of Investigational Devices Exemption (IDE) Applications (PDF Only) (PDF - 600KB) ODE/DCD/PVDB 974 10/26/96
Checklist of Information Usually Submitted in an Investigational Device Exemptions (IDE) Application for Refractive Surgery Lasers [excimer] ODE/DOED/DSDB 2093 10/10/96
Letter to Manufacturers of Prescription Home Monitors for Non-Stress Tests (PDF Only) (PDF - 104KB) ODE/DRARD/OGDB 1342 09/06/96
Letter to Manufacturers of Falloposcopes (PDF Only) (PDF - 110KB) ODE/DRARD/OGDB 1344 09/05/96
Memorandum of Understanding Regarding Patient Labeling Review (Blue Book Memo #G96-3) (Text Only) ODE 806 08/09/96
Continued Access to Investigational Devices During PMA Preparation and Review July 15, 1996 (Blue Book Memo) (D96-1) (Text Only) ODE 872 07/15/96
Suggested Format For IDE Progress Report (Text Only) ODE 311 06/01/96
Guidance Document For Testing Bone Anchor Devices ODE/DGRND/ORDB 915 04/20/96
Guidance Document for Testing Biodegradable Polymer Implant Devices (Text Only) ODE/DGRND/ORDB 914 04/20/96
510(k) Quality Review Program (Blue Book Memo I96-1) (Text Only) ODE 344 03/29/96
Thermal Endometrial Ablation Devices (Submission Guidance for an IDE) ODE/DRARD/OGDB 547 03/14/96
Hysteroscopes and Gynecology Laparoscopes - Submission Guidance for a 510(k) (PDF Version) (PDF - 1.2MB) ODE/DRARD/OGDB 907 03/07/96
Suggested Content for Original IDE Application Cover Letter (Text Only) ODE 797 02/27/96
Indications for Use Statement ODE 879 02/06/96

ODE Final Guidance Documents 1994 - 1995

TitleOrganizationDoc #Date
Guidance On The Content Of Premarket Notification [510(K)] Submissions For Protective Restraints (Text Only) ODE/DAGID 993 12/01/95
Cover Letter: 510(k) Requirements During Firm-Initiated Recalls; Attachment A: Guidance on Recall and Premarket Notification Review Procedures During Firm-Initiated Recalls of Legally Marketed Devices (blue book memo #K95-1) (Text Only) ODE 406 11/21/95
Addendum to: Guidance on Premarket Notification [510(k)] Submissions for Sterilizers Intended for Use in Health Care Facilities (Text Only) ODE/DAGID 1833 09/19/95
Implementation of the FDA/HCFA Interagency Agreement Regarding Reimbursement Categorization of Investigational Devices, Att. A Interagency Agreement, Att. B Criteria for Catergorization of Investigational Devices, & Att. C -List #D95-2 (blue book memo) (Text Only) ODE 106 09/15/95
HCFA Reimbursement Categorization Determinations for FDA-approved IDEs (PDF Only) (PDF - 291KB) ODE 4106 09/15/95
#D95-2, Attachment A (Interagency Agreement between FDA & HCFA) (PDF Only) (PDF - 356KB) ODE 2106 09/15/95
#D95-2, Attachment B (Criteria for Categorization of Investigational Devices (HCFA) (PDF Only) (PDF - 57KB) ODE 3106 09/15/95
Hysteroscopic And Laparoscopic Insufflators: Submission Guidance For A 510(K) (Text Only) ODE/DRARD/OGDB 1907 08/01/95
Guidance Document for the Preparation of Notification (510(k)) Applications for Therapeutic Massagers and Vibrators ODE/DGRND/REDB 818 07/26/95
Guidance Document For the Preparation of Premarket Notification [510(K)] Applications For Communications Systems (Powered and Non-Powered) and Powered Environmental Control Systems ODE/DGRND/REDB 762 07/26/95
Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Electromyograph Needle Electrodes ODE/DGRND/GSDB 325 07/26/95
Guidance Document for the Preparation of Premarket Notification [510(K)] Applications for Exercise Equipment ODE/DGRND/REDB 326 07/26/95
Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Heating and Cooling Devices ODE/DGRND/REDB 828 07/26/95
Guidance Document For the Preparation of Premarket Notification [510(K)] Applications For Immersion Hydrobaths ODE/DGRND/REDB 729 07/26/95
Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Powered Tables and Multifunctional Physical Therapy Tables ODE/DGRND/REDB 735 07/26/95
Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Submerged (Underwater) Exercise Equipment ODE/DGRND/REDB 307 07/26/95
Guidance Document for the Preparation of Premarket Notification [510k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three-Wheeled Vehicles ODE/DGRND/REDB 346 07/26/95
Goals and Initiatives for the IDE Program #D95-1 (blue book memo) (Text Only) ODE 405 07/12/95
Testing guidance for Male Condoms Made from New Material (Non-Latex) (Text Only) ODE/DRARD/OGDB 455 06/29/95
Guidance on the Content and Organization of a Premarket Notification for a Medical Laser ODE/DGRND/GSDB 386 06/01/95
Guidance Document for Testing Non-Articulating, 'Mechanically Locked', Modular Implant Components ODE/DGRND/ORDB 916 05/01/95
Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing' (Replaces #G87-1 #8294) (blue book memo)(Text Only) ODE 164 05/01/95
Guidance on Premarket Notification [510(K)] Submissions for Short-Term and Long-Term Intravascular Catheters (PDF Only) (PDF - 896KB) ODE/DAGID/GHDB 824 03/15/95
Guidance Document For The Preparation of Premarket Notification For Ceramic Ball Hip Systems ODE/DGRND/ORDB 355 01/10/95
Coronary and Cerebrovascular Guidewire Guidance (PDF Only) (PDF - 184KB) ODE/DCD/ICDB 964 01/01/95
Checklist for Mechanical Lithotripters and Stone Dislodgers used in Gastroenterology and Urology (PDF Only) (PDF - 15KB) ODE/DRARD/ULDB 98 11/01/94
510(k) Checklist for Sterile Lubricating Jelly Used With Transurethral Surgical Instruments (Text Only) ODE/DRARD/ULDB 892 09/19/94
Guidance for the Content of Premarket Notifications for Conventional and Antimicrobial Foley Catheters (Text Only) ODE/DRARD/ULDB 97 09/12/94
Guidance for the Preparation of a Premarket Notification for Extended Laparoscopy Devices (ELD) ODE/DGRND/GSDB 667 08/30/94
Guidance For The Content Of Premarket Notifications For Urodynamic/Uroflowmetry Systems (Text Only) ODE/DRARD/ULDB 490 07/29/94
Premarket Approval Application (PMA) Closure #P94-2 (blue book memo) (Text Only) ODE 403 07/08/94
Premarket Notification [510(k)] Guidance Document for Class II Daily Wear Contact Lenses ODE/DOED/VEDB 896 06/28/94
Guidance for the Content of Premarket Notifications for Urine Drainage Bags (PDF Only) (PDF - 500KB) ODE/DRARD/ULDB 96 06/07/94
510(k) Sign-Off Procedures #K94-2 (blue book memo) (Text Only) ODE 308 06/01/94
Letter to Industry, Powered Wheelchair/Scooter or Accessory/Component Manufacturer from Susan Alpert, Ph.D.,M.D. (PDF Only) (PDF - 265KB) ODE 883 05/26/94
IDE Refuse to Accept Procedures #D94-1 (blue book memo) (Text Only) ODE 410 05/20/94
Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone Or Bone Cement ODE/DGRND/ORDB 827 04/28/94
Preamendments Class III Strategy (Text Only) ODE 611 04/19/94
Battery Guidance (PDF Only) (PDF - 198KB) ODE/DCD 873 01/01/94

ODE Final Guidance Documents 1992 - 1993

TitleOrganizationDoc #Date
Excerpts Related to EMI from November 1993 Anesthesiology and Respiratory Devices Branch (includes EMI standard) (PDF Only) (PDF - 2.5MB) ODE/DAGID/ARDB 638 11/01/93
Reviewer Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators ODE/DAGID/ARDB 784 10/01/93
Guidance on the Content and Format of Premarket Notification [510(k)] Submissions for Sharps Containers (PDF Only) (PDF - 297KB) ODE/DAGID/INCB 895 10/01/93
Guidance on Premarket Notification [510(k)] Submissions for Automated Endoscope Washers, Washer/Disinfectors, and Disinfectors Intended for Use in Health Care Facilities (PDF Only) (PDF - 955KB) ODE/DAGID/INCB 881 08/01/93
Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes (PDF Only) (PDF - 635KB) ODE/DAGID/INCB 888 08/01/93
510(k) Additional Information Procedures #K93-1 (blue book memo) (Text Only) ODE 886 07/23/93
Center for Devices and Radiological Health's Investigational Device Exemption (IDE) Refuse to Accept Policy (PDF Only) (PDF - 349KB) ODE 4859 06/30/93
Classified Convenience Kits (PDF Only) (PDF - 137KB) ODE 789 04/30/93
Guidance on the Content of Premarket Notification [510(K)] Submissions for Hypodermic Single Lumen Needles (Text Only) ODE/DAGID/GHDB 450 04/01/93
Guidance on the Content of Premarket Notification [510(K)] Submissions for Piston Syringes (Text Only) ODE/DAGID/GHDB 821 04/01/93
Guidance on Premarket Notification 510(k) for Sterilizers Intended for Use in Health Care Facilities (PDF Only) (PDF - 843KB) ODE/DAGID 833 03/01/93
Guidance on the Content of Premarket Notification [510(K)] Submissions for Clinical Electronic Thermometers (Text Only) ODE/DAGID/GHDB 822 03/01/93
Guidance Document for the Preparation of IDE and PMA Applications for Intra-Articular Prosthetic Knee Ligament Devices ODE/DGRND/ORDB 233 02/18/93
Guidance for the Content of Premarket Notifications for Biopsy Devices Used in Gastroenterology and Urology (Text Only) ODE/DRARD/ULDB 482 02/10/93
Guidance for the Content of Premarket Notifications for Ureteral Stents (Text Only) ODE/DRARD/ULDB 431 02/10/93
Telephone Communications Between ODE Staff and Manufacturers #I93-1 (blue book memo) (Text Only) ODE 360 01/29/93
Policy for Expiration Dating (DCRND RB92-G) (PDF Only) (PDF - 59KB) ODE/DCD 137 10/30/92
Important Information About Rophae Intraocular Lenses (PDF Only) (PDF - 122KB) ODE/DOED/ICIB 811 08/20/92
Guidance for Peak Flow Meters for Over-the-Counter Sale (PDF Only) (PDF - 801KB) ODE/DAGID/ARDB 998 06/23/92
SMDA Changes - Premarket Notification; Regulatory Requirements for Medical Devices (510k) Manual Insert (PDF Only) (PDF - 84KB) ODE 655 04/17/92
Preamendment Class III Devices (PDF Only) (PDF - 417KB) ODE 584 03/11/92
Nondisclosure of Financially Sensitive Information #I92-1 (blue book memo) (Text Only) ODE 587 03/05/92
Document Review Processing #I91-1 (blue book memo) (Text Only) ODE 446 02/12/92

ODE Final Guidance Documents 1990 - 1991

TitleOrganizationDoc #Date
Heated Humidifier Review Guidance (PDF Only) (PDF - 166KB) ODE/DAGID/ARDB 780 08/30/91
Integrity of Data and Information Submitted to ODE #I91-2 (blue book memo) (Text Only) ODE 447 05/29/91
Panel Review of Premarket Approval Applications #P91-2 (blue book memo) (Text Only) ODE 444 05/03/91
PMA Compliance Program #P91-3 (blue book memo) (Text Only) ODE 445 05/03/91
Shelf Life of Medical Devices (PDF Only) (PDF - 1.7MB) ODE 415 04/01/91
Device Labeling Guidance #G91-1 (blue book memo) (Text Only) ODE 414 03/08/91
Consolidated Review of Submissions for Diagnostic Ultrasound Equipment, Accessories and Related Measurement Devices #G90-2 (blue book memo) (Text Only) ODE 30 10/19/90
Consolidated Review of Submissions for Lasers and Accessories #G90-1 (blue book memo) (Text Only) ODE 31 10/19/90
Guidance on 510(k) Submissions for Implanted Infusion Ports (PDF Only) (PDF - 787KB) ODE/DAGID/GHDB 392 10/01/90
Premarket Testing Guidelines for Female Barrier Contraceptive Devices also intended to prevent sexually transmitted diseases (PDF Only) (PDF - 714KB) ODE/DRARD/OGDB 384 04/04/90
Policy Development and Review Procedures #I90-1 (blue book memo) (Text Only) ODE 368 02/15/90
Reviewer Guidance for Automatic X-Ray Film Processor 510(k) (PDF Only) (PDF - 86KB) ODE/DRARD 788 02/01/90
Implantable Pacemaker Testing Guidance (PDF Only) (PDF - 489KB) ODE/DCD/PDLB 383 01/12/90
Threshold Assessment of the Impact of Requirements for Submission of PMAs for 31 Medical Devices Marketed Prior to May 28, 1976 (PDF Only) (PDF - 546KB) ODE 352 01/01/90

ODE Final Guidance Documents 1976 - 1989

TitleOrganizationDoc #Date
Meetings with the Regulated Industry #I89-3 (blue book Memo) ODE 367 11/20/89
Toxicology Risk Assessment Committee #G89-1 (blue book memo) (Text Only) ODE 363 08/09/89
New FDA Recommendations & Results of Contact Lens Study (7 day letter) (PDF Only) (PDF - 147KB) ODE/DOED/VEDB 265 05/30/89
Review of IDEs for Feasibility Studies #D89-1 (blue book memo) (Text Only) ODE 362 05/17/89
Premarket Notification - Consistency of Reviews #K89-1 (blue Book memo) (Text Only) ODE 339 02/28/89
Guidance for Oxygen Conserving Device 510(k) Review 73 BZD 868.5905 Non-continuous Ventilator Class II (PDF Only) (PDF - 100KB) ODE/DAGID/ARDB 583 02/01/89
Balloon Valvuloplasty Guidance For The Submission Of an IDE Application and a PMA Application (Text Only) ODE/DCD 370 01/01/89
Guidance for Studies for Pain Therapy Devices - General Consideration in the Design of Clinical Studies for Pain-Alleviating Devices ODE/DGRND/REDB 640 05/12/88
Review of Laser Submissions #G88-1 (blue book memo) (Text Only) ODE 330 04/22/88
ODE Executive Secretary Guidance Manual G87-3 ODE 1338 08/07/87
Master Files Part III; Guidance on Scientific and Technical Information (PDF Only) (PDF - 318KB) ODE 338 06/01/87
Industry Representatives on Scientific Panel (PDF Only) (PDF - 169KB) ODE 329 03/23/87
Panel Report and Recommendations on PMA Approvals #P86-5 (blue book memo) (Text Only) ODE 306 04/18/86
Points to Consider in the Characterization of Cell Lines Used to Produce Biological Products ODE 269 06/01/84
Application of the Device Good Manufacturing Practice (GMP) Regulation to the Manufacture of Sterile Devices (PDF Only) (PDF - 716KB) ODE 267 12/01/83
Guidance ('Guidelines') for Evaluation of Hysteroscopic Sterilization Devices ODE/DRARD/OGDB 248 05/10/78
Guidance ('Guidelines') for Evaluation of Laparoscopic Bipolar and Thermal Coagulators (and Accessories) (PDF Only) (PDF - 230KB) ODE/DRARD/OGDB 232 05/01/78
Guidance ('Guidelines') for Evaluation of Tubal Occlusion Devices (PDF Only) (PDF - 258KB) ODE/DRARD/OGDB 245 11/22/77
Guidance ('Guidelines') for Evaluation of Fetal Clip Electrode (PDF Only) (PDF - 15KB) ODE/DRARD/OGDB 244 03/08/77
Guidelines for Evaluation of Non-Drug IUDs ODE/DRARD/OGDB 641 09/26/76
Review Guidance for Oxygen Generators and Oxygen Equipment (PDF Only) (PDF - 260KB) ODE/DAGID/ARDB 986 02/10/09

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