Radiological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting. (29NOV02)
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Establishment of Medical Device User Fee Rates for Fiscal Year 2003 and Interim Procedures. (21NOV02)
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Medical Devices; Classification for Medical Washer and Medical Washer-Disinfector. (15NOV02)
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Agency Information Collection Activities; Submission for OMB Review; Comment Request; Medical Device Recall
Authority. (13NOV02)
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Medical Devices; Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep
Apnea; Guidance for Industry and FDA; Availability. (12NOV02)
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The Guidance (.doc)
The Guidance (.pdf) |
Dental Devices; Classification for Intraoral Devices for Snoring and/or Obstructive Sleep Apnea. (12NOV02)
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Medical Devices; Class II Special Controls Guidance Document: Transcutaneous Air Conduction Hearing Aid System; Guidance
for Industry and FDA; Availability.
(07NOV02)
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The Guidance (.doc)
The Guidance (.pdf) |
Medical Devices; Ear, Nose, and Throat Devices; Classification of the Transcutaneous Air Conduction Hearing Aid System.
(07NOV02)
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Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications. (06NOV02)
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Diagnostic X-Ray Field Size; Revocation of Compliance Policy Guide 7133.17; Correction. (01NOV02)
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Determining Hospital Procedures for Opened-But-Unused, Single-Use Medical Devices; Request for Comments and Information;
Correction of docket number from ''[Docket No. 00D–0053]'' is corrected to read ''[Docket No. 02N–0456]''. (29OCT02)
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Neurological Devices; Classification of Human Dura Mater. (22OCT02)
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Draft Guidance for Industry on Class II Special Controls Guidance Document: Human Dura Mater; Availability. (22OCT02)
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Agency Information Collection Activities; Submission for OMB Review; Comment Request; Medical Devices: Humanitarian Use
Devices. (18OCT02)
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Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting. (17OCT02)
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Agency Information Collection Activities; Submission for OMB Review; Comment Request; Reclassification Petitions for
Medical Devices. (16OCT02)
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Diagnostic X-Ray Field Size; Revocation of Compliance Policy Guide 7133.17. (10OCT02)
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Medical Devices: The Least Burdensome Provisions of the FDA Modernization Act of 1997; Concept and Principles;
Availability. (04OCT02)
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FDA Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 007. (02OCT02)
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Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Reporting: Manufacturer
Reporting, Importer Reporting, User Facility Reporting, and Distributor Reporting (01OCT02)
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Radiological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting. (20SEP02)
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Medical Devices;Class II Special Controls Guidance Document; Cyclosporine and Tacrolimus Assays; Availability. (16SEP02)
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Agency Information Collection Activities; Submission for OMB Review; Comment Request; Dissemination of Information on
Unapproved/New Uses for Marketed Drugs, Biologics, and Devices. (16SEP02)
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Clinical Chemistry and Clinical Toxicology Devices; Reclassification of Cyclosporine and Tacrolimus Assays. (16SEP02)
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Draft Guidance for Industry: Drugs, Biologics, and Medical Devices Derived From Bioengineered Plants for Use in Humans and
Animals; Availability. (12SEP02)
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Medical Devices; Draft Guidance; Medical Devices Made With Polyvinylchloride Using the Plasticizer
di-(2-Ethylhexyl)phthalate; Availability.
(06SEP02)
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Orthopedic Devices; Denial of Request for Change in Classification of Hip Joint Metal/Metal Semi-Constrained, With a
Cemented Acetabular Component, Prosthesis and Hip Joint Metal/Metal Semi-Constrained, With an Uncemented Acetabular Component, Prosthesis. (06SEP02)
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Class III Medical Devices Without Premarket Clearance; Revocation of Compliance Policy Guide 7124.30. (05SEP02)
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Draft Guidance for Industry, Electronic Records; Electronic Signatures, Maintenance of Electronic Records; Availability.
(05SEP02)
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The Draft Guidance |
Determining Hospital Procedures for Opened-But-Unused, Single-Use Medical Devices; Request for Comments and Information.
(28AUG02)
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Medical Device Use in the Home Health Care Community; Public Meeting. (20AUG02)
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Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting (20AUG02)
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Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Recall Authority.
(19AUG02)
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Dental Devices; Classification of the Dental Sonography Device and the Jaw Tracking Device. (14AUG02)
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Medical Devices; Class II Special Controls Guidance Document: Dental Sonography Device and the Jaw Tracking Devices; Draft
Guidance for Industry and FDA Reviewers; Availability. (14AUG02)
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Dental Products Panel of the Medical Devices Advisory Committee; Notice of Meeting. (01AUG02)
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Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices: Humanitarian Use Devices.
(31JUL02)
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Ear, Nose, and Throat Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting. (25JUL02)
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Agency Information Collection Activities; Proposed Collection; Comment Request; Reclassification Petitions for Medical
Devices. (22JUL02)
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Dental Devices: Classification of Encapsulated Amalgam Alloy and Dental Mercury and Reclassification of Dental Mercury;
Issuance of Special Controls for Amalgam Alloy. (17JUL02)
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Medical Devices: Class II Special Controls Guidance Document: Apnea Monitors; Guidance for Industry and FDA; Availability.
(17JUL02)
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Draft Special Control Guidance Document on Encapsulated Amalgam, Amalgam Alloy and Dental Mercury Labeling;
Availability. (17JUL02)
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Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications. (17JUL02)
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Medical Devices; Apnea Monitor; Special Controls. (17JUL02)
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Medical Devices; Reclassification of Polymethylmethacrylate (PMMA) Bone Cement. (17JUL02)
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Agency Information Collection Activities; Submission for OMB Review; Comment Request; Regulations for In Vivo
Radiopharmaceuticals Used for Diagnosis and Monitoring. (16JUL02)
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Denture Cleaners, Adhesives, Cushions, and Repair Materials; Revocation of Compliance Policy Guide 7124.05. (08JUL02)
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Opthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting. (08JUL02)
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General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting. (03JUL02)
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Medical Devices; Cardiac Ablation Catheters Generic Arrhythmia Indications for Use; Guidance for Industry;
Availability. (01JUL02)
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Agency Information Collection Activities; Submission for OMB Review; Comment Request; Medical Devices; Notification of a
Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body. (28JUN02)
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Medical Devices; Needle-Bearing Devices; Request for Comments and Information. (20JUN02)
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Medical Devices; Guidance for Resorbable Adhesion Barrier Devices for Use in Abdominal and/or Pelvic Surgery; Availability.
(18JUN02)
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Obstetric and Gynocology Devices; Effective Date of Requirement for Premarket Approval for Glans Sheath Devices.
(14JUN02)
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Medical Devices; Implantable Middle Ear Hearing Device; Draft Guidance for Industry and FDA; Availability. (12JUN02)
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Agency Information Collection Activities; Submission for OMB Review; Comment Request; Medical Devices; State Petitions for
Exemption from Preemption. (30MAY02)
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Medical Device Public Workshop. (28MAY02)
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Agency Information Collection Activities; Announcement of OMB Approval; Emergency Medical Device Shortage Program Survey.
(22MAY02)
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Supporting Statement |
Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications. (22MAY02)
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Agency Information Collection Activities; Announcement of OMB Approval; Medical Devices; Device Tracking. (15MAY02)
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Supporting Statement |
Dental Devices; Reclassification of Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments.
(14MAY02)
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Medical Devices; Draft Guidance for Industry and FDA on Class II Special Controls: Root-Form Endosseous Dental Implants
and Abutments; Availability. (14MAY02)
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Technical Electronic Products Radiation Safety Standards Committee; Notice of Meeting. (02MAY02)
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Medical Devices; Class II Special Controls Guidance Document: Hip Joint Metal/Polymer Constrained Cemented or Uncemented
Prosthesis; Availability. (30APR02)
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Orthopedic Devices: Reclassification of the Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis.
(30APR02)
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Medical Devices: Class II Special Controls Guidance Document: Endolymphatic Shunt Tube With Valve; Final Guidance for
Industry Availability. (29APR02)
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Medical Devices; Ear, Nose and Throat Devices; Reclassification of the Endolymphatic Shunt Tube With Valve. (29APR02)
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Agency Information Collection Activities; Proposed Collection; Comment Request; Dissemination of Information on
Unapproved/New Uses for Marketed Drugs, Biologics, and Devices. (16APR02)
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Agency Information Collection Activities; Announcement of OMB Approval; Medical Device Labeling Regulations. (16APR02)
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Dental Devices; Classification for Intraoral Devices for Snoring and/or Obstructive Sleep Apnea. (05APR02)
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Medical Devices: Draft Guidance on Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or
Obstructive Sleep Apnea; Draft Guidance for Industry and FDA; Availability. (05APR02)
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Agency Information Collection Activities; Announcement of OMB Approval; Medical Device Registration and Listing.
(05APR02)
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