Guidance On The Content Of Premarket Notification [510(K)] Submissions For Protective Restraints (Text Only)
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ODE/DAGID
|
993
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12/01/95
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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)
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ODE
|
406
|
11/21/95
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Addendum to: Guidance on Premarket Notification [510(k)] Submissions for Sterilizers Intended for Use in Health Care Facilities (Text Only)
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ODE/DAGID
|
1833
|
09/19/95
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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)
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ODE
|
106
|
09/15/95
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HCFA Reimbursement Categorization Determinations for FDA-approved IDEs (PDF Only) (PDF - 291KB)
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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)
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ODE/DRARD/OGDB
|
1907
|
08/01/95
|
Guidance Document for the Preparation of Notification (510(k)) Applications for Therapeutic Massagers and Vibrators
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ODE/DGRND/REDB
|
818
|
07/26/95
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Guidance Document For the Preparation of Premarket Notification [510(K)] Applications For Communications Systems (Powered and Non-Powered) and Powered Environmental Control Systems
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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
|