Medical Devices

Office of Compliance Final Guidance

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 For a list of current draft guidance documents, please see the Draft Guidance page.

Some Web links (URLs) embedded within guidance documents are no longer valid. If you find a link that does not work, please try searching for the document using the document title.

OC Final Guidance Documents

TitleOrganizationDoc #Date
Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions - Guidance for Industry and Food and Drug Administration Staff (PDF - 870KB) OC 1500065 12/27/16
Distinguishing Medical Device Recalls from Medical Device Enhancements - Guidance for Industry and Food and Drug Administration Staff (PDF - 360KB) CDRH/OC/DAPO 1819 10/15/14
Custom Device Exemption - Guidance for Industry and Food and Drug Administration Staff (PDF - 549KB) CDRH/ODE CDRH/OC 1820 09/24/14
Medical Device Tracking - Guidance for Industry and Food and Drug Administration Staff OC 169 03/27/14
Guidance for Industry and FDA Staff - 30-Day Notices, 135-Day Premarket Approval (PMA) Supplements and 75-Day Humanitarian Device Exemption (HDE) Supplements for Manufacturing Method or Process Changes CDRH/OC CBER 1687 04/13/11
Inspection of Medical Device Manufacturers (PDF - 707KB) OC/DPO/FPB 02/02/11
(Withdrawn) Guidance for Industry, Third Parties and Food and Drug Administration Staff - Medical Device ISO 13485:2003 Voluntary Audit Report Submission Pilot Program CBER CDRH 1764 03/19/12
Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300 OC/DE2/OBGUB 1688 12/23/08
Surveillance and Detention Without Physical Examination of Surgeons’ and/or Patient Examination Gloves OC/DE2 1141 07/11/08
Surveillance and Detention Without Physical Examination of Condoms OC/DE2 1139 07/11/08
The Review and Inspection of Premarket Approval Application Manufacturing Information and Operations OIVD OC 1566 01/08/08
Decorative, Non-corrective Contact Lenses OC/DE1 1613 11/24/06
Compliance with Section 301 of the Medical Device User Fee and Modernization Act of 2002, as amended - Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices OC 1217 05/01/06
Guidance for Industry - Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software ODE OC 1553 01/14/05
User Labeling for Devices that Contain Natural Rubber (21 CFR 801.437); Small Entity Compliance Guide OC 1212 04/01/03
Quality System Information for Certain Premarket Application Reviews; Guidance for Industry and FDA Staff OC/DE3 1140 02/03/03
General Principles of Software Validation; Final Guidance for Industry and FDA Staff CBER CDRH/OC 938 01/11/02
Sterilized Convenience Kits for Clinical and Surgical Use OC 1390 01/07/02
Labeling Recommendations for Single-Use Devices Reprocessed by Third Parties and Hospitals; Final Guidance for Industry and FDA OC/DE3 1392 07/30/01
Labeling for Electronic Anti-Theft Systems OC/DE3 1170 08/15/00
Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals OC/DE3 1168 08/14/00
Alternative to Certain Prescription Device Labeling Requirements OC 1150 01/21/00
Guidance on Electrosurgical Devices and the Application of the Performance Standard for Electrode Lead Wires and Patient Cables (PDF - 19KB) OC/DE1 1129 11/15/99
Preparing Notices of Availability of Investigational Medical Devices and for Recruiting Study Subjects OC/DBM 2229 03/19/99
Information about Lasers: An Important Letter to Ophthalmologists About Lasers for Refractive Surgery OC/DE2 8323 06/27/97
Design Control Guidance For Medical Device Manufacturers OC/DE3 994 03/11/97
Prospective Manufacturers of Barrier Devices Used During Oral Sex for STD Protection OC/DE2 1394 10/31/96
Letter to Manufacturers and Initial Distributors of Hemodialyzers (PDF only) (PDF - 360KB) OC/DE2 2507 05/23/96
Reuse of Medical Disposable Devices Policy OC/DE3 961 12/27/95
Letter to Medical Device Manufacturer on Pentium processors (PDF only) (PDF - 100KB) OC 456 02/14/95
Pesticide Regulation Notice 94-4 Interim Measures for the Registration of Antimicrobial Products/Liquid Chemical Germicides with Medical Device Use Claims (PDF only) (PDF - 939KB) OC/DE2 851 06/30/94
All Device Manufacturers/Repackers Using Cotton (PDF Version) (PDF - 105KB) OC/DE2 101 04/22/94
Letter - Condom Manufacturers and Distributors (PDF only) (PDF - 124KB) OC/DE2 56 04/05/94
Letter - Manufacturers, Distributors and Importers of Condom Products (included in Condom Packet 398) (PDF only) (PDF - 75KB) OC/DE2 52 02/23/94
Manufacturers And Initial Distributors Of Sharps Containers And Destroyers Used By Health Care Professionals (PDF - 199KB) OC/DE2 933 02/03/94
Endoscopy and Laparoscopy Accessories (PDF - 110KB) OC/DE1 545 05/17/93
Letter to Industry, Powered Wheelchair Manufacturers from RMJohnson (PDF - 47KB) OC/DE2 869 05/10/93
Latex Labeling Letter (Johnson) (PDF - 97KB) OC/DE2 831 03/18/98
Dental Handpiece Sterilization (Dear Doctor Letter) (PDF only) (PDF - 73KB) OC/DE2 589 09/28/92
Commercial Distribution/Exhibit Letter (PDF - 55KB) OC 246 04/10/92
Quality Assurance Guidelines for Hemodialysis Devices (PDF - 12.7MB) OC/DE3 507 02/01/91
Letter - Manufacturers, Importers, and Repackagers of Condoms for Contraception or Sexually-Transmitted Disease Prevention (Holt) (PDF only) (PDF - 76KB) OC/DE2 53 02/13/89
Color Additive Status List (PDF Only) (PDF - 379KB) OC 268 02/01/89
Color Additive Petitions (PDF - 91KB) OC 296 06/01/87
Condoms: Inspection and Sampling at Domestic Manufacturers and of all Repackers; Sampling from all Importers (Damaska Memo to Field on 4/8/87) (PDF - 240KB) OC/DE2 293 04/08/87
All U.S. Condom Manufacturers, Importers and Repackagers (PDF only) (PDF - 94KB) OC/DE2 2510 04/07/87
Standard Specification for Rubber Contraceptives (Condoms) (PDF Only) (PDF - 552KB) OC/DE2 628 10/28/83
Ethylene Oxide; Ethylene Chlorohydrin; and Ethylene Glycol; Proposed Maximum Residue Limits and Maximum Levels of Exposure (PDF only) (PDF - 1.4MB) OC/DE2 1019 06/23/78

Page Last Updated: 12/23/2016
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