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
|
ODE
|
585
|
09/09/99
|
Guidance for Industry and/or for FDA Reviewers/Staff and/or Compliance: Guidance for the Submission of 510(k)’s for Solid State X-ray Imaging Devices
|
ODE/DRARD
|
644
|
08/06/99
|
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: Guidance for the Submission Of Premarket Notifications for Magnetic Resonance Diagnostic Devices
|
ODE/DRARD
|
340
|
11/14/98
|
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
|