Medical Devices

ODE Guidance 1976 - 1997

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ODE Guidance Documents 1996 - 1997

Title	Organization	Doc #	Date
Distribution and Public Availability of Premarket Approval Application Summary of Safety and Effectiveness Data Packages - October 10, 1997 (P97-1) (Text Only)	ODE	563	10/10/97
Notice to Manufacturers of Bone Mineral Densitometers	ODE/DRARD	552	09/25/97
(Withdrawn) Discussion Points for Expansion of the "Checklist of Information Usually Submitted in an Investigational Device Exemption (IDE) Application for Refractive Surgery Lasers" Draft Document	ODE/DOED/DSDB	7093	09/05/97
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	ODE/DRARD/OGDB	1342	09/06/96
Letter to Manufacturers of Falloposcopes	ODE/DRARD/OGDB	1344	09/05/96
Questions and Answers for the FDA Reviewer Guidance: Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities (PDF Only) (PDF - 1023KB)	ODE	1198	09/03/96
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 for Testing MR Interaction with Aneurysm Clips, Draft Document	ODE/DGRND/PRSB	958	05/22/96
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
Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: FDA Reviewer Guidance (PDF Only) (PDF - 1.3MB)	ODE	198	04/01/96
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 Gynecologic Laparoscopes - Submission Guidance for a 510(k)	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 Guidance Documents 1994 - 1995

Title	Organization	Doc #	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
Draft Reviewer Guidance for Ventilators (PDF Only) (PDF - 1.1MB)	ODE/DAGID/ARDB	500	07/01/95
Testing guidance for Male Condoms Made from New Material (Non-Latex) (Text Only)	ODE/DRARD/OGDB	455	06/29/95
(Withdrawn) Memorandum: Electromagnetic Compatibility for Medical Devices: Issues and Solutions (PDF Only) (PDF - 15KB)	ODE	639	06/13/95
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
510(k) Refuse to Accept Procedures #K94-1 (blue book memo) (Text Only)	ODE	401	05/20/94
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
Draft Reviewer Guidance on Face Masks and Shield for CPR (PDF Only) (PDF - 53KB)	ODE/DAGID/ARDB	996	03/16/94
Premarket Notification [510(k)] Status Request Form	ODE	858	03/07/94
Draft 510(K) Submission Requirements for Peak Flow Meters (PDF Only) (PDF - 69KB)	ODE/DAGID/ARDB	999	01/13/94
Battery Guidance (PDF Only) (PDF - 198KB)	ODE/DCD	873	01/01/94

ODE Guidance Documents 1992 - 1993

Title	Organization	Doc #	Date
(Withdrawn) Documentation and Resolution of Differences of Opinion on Product Evaluations #G93-1 (blue book memo)	ODE	920	12/23/93
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
Center for Devices and Radiological Health's Premarket Notification [510(k)] Refuse to Accept Policy - (updated Checklist 3/14/1995) (PDF Only) (PDF - 406KB)	ODE	3859	06/30/93
Classified Convenience Kits (PDF Only) (PDF - 137KB)	ODE	789	04/30/93
Draft Emergency Resuscitator Guidance (PDF Only) (PDF - 113KB)	ODE/DAGID/ARDB	985	04/14/93
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
Draft Guidance for Preparation of PMA Applications for Testicular Prostheses (Text Only)	ODE/DRARD/ULDB	809	03/16/93
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
General Guidance Document: Non-Invasive Pulse Oximeter (PDF Only) (PDF - 625KB)	ODE/DAGID/ARDB	997	09/07/92
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 Guidance Documents 1990 - 1991

Title	Organization	Doc #	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
Assignment of Review Documents #I90-2 (blue book memo) (Withdrawn)	ODE	366	08/24/90
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
Guidance on the CDRH Premarket Notification Review Program 6/30/86 (K86-3)	ODE	390	01/01/90
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 Guidance Documents 1976 - 1989

Title	Organization	Doc #	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
(Withdrawn) Limulus Amebocute Lysate; Reduction of Samples for Testing (PDF - 44KB)	ODE	178	10/23/87
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