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
|
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
|
Guidance for Industry and FDA Staff - Implementation of Medical Device Establishment Registration and Device Listing Requirements Established by the Food and Drug Administration Amendments Act of 2007
|
OC/DRMO/RPSB
|
1657
|
10/08/09
|
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
|
Medical Device Tracking; Guidance for Industry and FDA Staff
|
OC
|
169
|
01/25/10
|
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
|
The Review and Inspection of Premarket Approval Applications under the Bioresearch Monitoring Program
|
OC/DBM
|
1602
|
01/08/08
|
Class II Special Controls Guidance Document: Oxygen Pressure Regulators and Oxygen Conserving Devices
|
OC
|
1227
|
02/27/07
|
Decorative, Non-corrective Contact Lenses
|
OC/DE1
|
1613
|
11/24/06
|
Inspection of Medical Device Manufacturers
|
OC/DPO/FPB
|
|
06/15/06
|
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
|
WITHDRAWN: Draft Guidance for Industry and FDA Staff - Functional Indications for Implantable Cardioverter Defibrillators
|
ODE
OC
|
1304
|
10/06/05
|
Guidance for Industry - Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software
|
ODE
OC
|
1553
|
01/14/05
|
(Withdrawn) Consumer-Directed Broadcast Advertising of Restricted Devices
|
OC
|
1513
|
02/10/04
|
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
|
Implementation of the Biomaterials Access Assurance Act of 1998
|
OC
|
1324
|
04/02/01
|
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 version) (PDF - 19KB)
|
OC/DE1
|
1129
|
11/15/99
|
(Withdrawn) Guidance for FDA Staff: Civil Money Penalty Policy
|
OC
|
1124
|
06/08/99
|
Preparing Notices of Availability of Investigational Medical Devices and for Recruiting Study Subjects
|
OC/DBM
|
2229
|
03/19/99
|
Performance Standard for Electrode Lead Wires and Patient Cables
|
OC
|
1197
|
03/16/98
|
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
|
Electromagnetic Compatibility - A Letter to Industry
|
OC/DE3
|
1087
|
09/18/96
|
Shielded Trocars and Needles used for Abdominal Access during Laparoscopy (PDF Version) (PDF - 87KB)
|
OC/DE2
|
1122
|
08/23/96
|
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
|
Medical Devices and EMI: The FDA Perspective
|
OC/DE3
|
1082
|
01/01/95
|
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 Version) (PDF - 199KB)
|
OC/DE2
|
933
|
02/03/94
|
Endoscopy and Laparoscopy Accessories (PDF only) (PDF - 110KB)
|
OC/DE1
|
545
|
05/17/93
|
Letter to Industry, Powered Wheelchair Manufacturers from RMJohnson (PDF Only) (PDF - 47KB)
|
OC/DE2
|
869
|
05/10/93
|
Latex Labeling Letter (Johnson) (PDF only) (PDF - 97KB)
|
OC/DE2
|
831
|
03/18/98
|
Dental Handpiece Sterilization (Dear Doctor Letter) (PDF only) (PDF - 73KB)
|
OC/DE2
|
589
|
09/28/92
|
Computerized Devices/Processes Guidance (PDF Version) (PDF - 1.3MB)
|
OC/DE3
|
247
|
05/01/92
|
Commercial Distribution/Exhibit Letter (PDF only) (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 Only) (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 only) (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
|
Medical Device Electromagnetic Interference Issues, Problem Reports, Standards, and Recommendations (PDF Version) (PDF - 759KB)
|
OC/DE3
|
1086
|
|