Medical Devices; Exemptions From Premarket Notification; Class II Devices. (15DEC00)
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Prepublication display |
Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval. (15DEC00)
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Prepublication display |
Human Bone Allograft: Manipulation and Homologous Use in Spine and Other Orthopedic Reconstruction and Repair; Public
Meeting; Reopening of Comment Period. (13DEC00)
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Prepublication display |
Agency Information Collection Activities; Announcement of OMB Approval; Agreement for Shipment of Devices for
Sterilization. (12DEC00)
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Prepublication display
Supporting Statement |
Agency Information Collection Activities; Announcement of OMB Approval; Latex Condoms; User Labeling; Expiration
Dating. (12DEC00)
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Prepublication display
Supporting Statement |
Medical Device; Exemption From Premarket Notification; Class II Devices; Barium Enema Retention Catheters and Tips With or
Without a Bag. (08DEC00)
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Prepublication display |
Agency Information Collection Activities; Announcement of OMB Approval; Reporting and Recordkeeping Requirements and
Availability of Sample Electronic Products for Manufacturers and Distributors of Electronic Products. (05DEC00)
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Prepublication display
Supporting Statement
|
Agency Information Collection Activities; Announcement of OMB Approval; Export of Medical Devices--Foreign Letters of
Approval. (05DEC00)
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Prepublication display
Supporting Statement |
Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting. (01DEC00)
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Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting. (28NOV00)
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Immunology and Microbiology Devices; Classification of Anti-Saccharomyces cerevisiae (S. cerevisiae) Antibody (ASCA) Test
Systems. (22NOV00)
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Guidance for Industry and FDA Reviewers: Class II Special Control Guidance Document for Anti-Saccharomyces cerevisiae (S.
cerevisiae) Antibody (ASCA) Premarket Notifications; Availability. (22NOV00)
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The Guidance |
Guidance Documents for Premarket Notification (510(k)) Submissions for Indwelling Blood Gas Analyzers; Availability.
(22NOV00)
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Prepublication display
The Guidance |
Medical Devices; Reclassification of 38 Preamendments Class III Devices into Class II. (22NOV00)
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Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting. (21NOV00)
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Prepublication display |
Medical Devices Draft Guidance on Over the Counter (OTC) Screening Tests for Drugs of Abuse: Guidance for Premarket
Notifications; Availability. (14NOV00)
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Prepublication display
The Draft Guidance |
Medical Devices Draft Guidance on Guidance for Prescription Use Drugs of Abuse Assays Premarket Notifications;
Availability. (14NOV00)
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Prepublication display
The Draft Guidance |
Radiological health Reengineering; Public Workshop. (09NOV00)
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Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting. (06NOV00)
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Prepublication display |
Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting.
(03NOV00)
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Gastroenterology and Urology Devices; Effective Date of the Requirement for Premarket Approval of the Implanted
Mechanical/Hydraulic Urinary Continence Device; Correction. (30OCT00)
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Prepublication display |
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Reporting and Recordkeeping
Requirements for Mammography Facilities. (26OCT00)
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Prepublication display |
Medical Devices Dispute Resolution Panel of the Medical Devices Advisory Committee; Notice of Meeting. (23OCT00)
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Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting. (19OCT00)
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Draft Guidance Topical Dermatological Drug Product NDAs & ANDAs |
Radiological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting. (19OCT00)
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Prepublication display |
Medical Devices; Labeling for Menstrual Tampon for the ``Ultra'' Absorbency. (18OCT00)
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Medical Devices; Exemption From Premarket Notification; Class II Devices; Triiodothyronine Test System. (18OCT00)
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Medical Devices; Labeling for Menstrual Tampons; Ranges of Absorbency, Change From ``Junior'' to ``Light''. (18OCT00)
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Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting. (18OCT00)
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Dental Products Devices; Reclassification of Endosseous Dental Implant Accessories. (10OCT00)
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Mutual Recognition Agreement, Medical Device Annex; Confidence Building Activities: Availability of Draft Guidances.
(03OCT00)
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Prepublication display
The Draft Guidance
The Draft Guidance |
Dental Products Panel of the Medical Devices Advisory Committee; Notice of Meeting. (28SEP00)
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Gastroenterology and Urology Devices; Effective Date of Requirement for Premarket Approval of the Implanted
Mechanical/Hydraulic Urinary Continence Device. (26SEP00)
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Prepublication document |
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Latex Condoms; User Labeling;
Expiration Dating. (25SEP00)
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Prepublication document |
Medical Devices; Apnea Monitor; Special Controls. (22SEP00)
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Medical Devices; Performance Standard for the Infant Apnea Monitor; Withdrawal Notice. (22SEP00)
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Draft Guidance for Infant/Child Apnea Monitor 510(k) Submissions; Availability. (22SEP00)
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Prepublication document
The Draft Guidance |
Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting. (22SEP00)
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Prepublication document |
Agency Information Collection Activities; Announcement of OMB Approval; Administrative Detention and Banned Medical
Devices. (19SEP00)
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Prepublication document
Supporting Statement
|
Medical Devices; CLIA Waiver Criteria; Public Workshop. (15SEP00)
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Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices;
Classification/Reclassification; Restricted Devices: Analyte Specific Reagents. (14SEP00)
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Prepublication document |
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Agreement for Shipment of Devices
for Sterilization. (14SEP00)
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Prepublication document |
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Reporting and Recordkeeping
Requirements and Availability of Sample Electronic Products for Manufacturers and Distributors of Electronic Products. (13SEP00)
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Prepublication document |
Draft Compliance Guidance: The Mammography Quality Standards Act Final Regulations Document 1B4; Availability. (13SEP00)
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Prepublication document
The Draft Guidance
|
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Export of Medical Devices_Foreign
Letters of Approval. (12SEP00)
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Prepublication document |
Agency Information Collection Activities; Announcement of OMB Approval; Investigational Device Exemptions, Reports, and
Records. (12SEP00)
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Prepublication document
Supporting Statement |
Neurological Devices; Reclassification of the Totally Implanted Spinal Cord Stimulator. (06SEP00)
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Prepublication document |
Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications. (06SEP00)
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Prepublication document |
Draft Guidance for Industry; Special Control Guidance for Premarket Notifications for Totally Implanted Spinal Cord
Stimulators for Pain Relief; Availability. (06SEP00)
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Prepublication document
The Draft Guidance
|
Postmarket Surveillance. (29AUG00)
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Prepublication document |
Amendment of Various Device Regulations to Reflect Current American Society for Testing and Materials Citations,
Confirmation in Part and Technical Amendment; Correction. (24AUG00)
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Prepublication document |
Physical Medicine Devices; Revision of the Identification of the Ionotophoresis Device. (22AUG00)
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Prepublication document |
Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting. (22AUG00)
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Joint Meeting of the Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee With the Pregnancy Labeling
Subcommittee of the Advisory Committee for Reproductive Health Drugs; Notice of Meeting. (22AUG00)
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Prepublication document |
Registration and Listing and MDR Baseline Reporting Grassroots Meetings for Medical Device Manufacturers. (16AUG00)
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Prepublication document |
Draft Guidance for Industry on Administrative Procedures for CLIA Categorization; Availability. (14AUG00)
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Prepublication document
The Draft Guidance |
Guidance for Industry on Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals;
Availability. (14AUG00)
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Prepublication document
The Guidance |
Draft Guidance for Industry on Surveillance and Detention Without Physical Examination of Condoms; Availability. (14AUG00)
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Prepublication document
The Draft Guidance |
Gastroenterology and Urology Devices; Reclassification of the Extracorporeal Shock Wave Lithotripter. (09AUG00)
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Prepublication document |
Guidance for the Content of Premarket Notifications (510(k)s) for Extracorporeal Shock Wave Lithotripters Indicated for
the Fragmentation of Kidney and Ureteral Calculi: Availability. (09AUG00)
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Prepublication document
The Guidance
|
Guidance for Industry and for FDA Reviewers: Guidance on Section 216 of the Food and Drug Administration Modernization Act
of 1997; Availability. (09AUG00)
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Prepublication document
The Guidance
|
Medical Devices; Exemption From Premarket Notification; Class II Devices. (08AUG00)
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Medical Devices; Anesthesiology Devices; Classification of Devices to Relieve Upper Airway Obstruction; Correction.
(03AUG00)
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Prepublication document |
Obstetrical and Gynecological Devices; Classification of the Clitoral Engorgement Device. (02AUG00)
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The Guidance Document |
Draft Guidance for Industry on Refractive Implants: Investigational Device Exemptions (IDE's) and Premarket Approval
Applications (PMA's); Availability. (01AUG00)
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Prepublication document
The Draft Guidance |
Revised Draft Guidance for Industry on Developing Medical Imaging Drugs and Biologics; Availability. (31JUL00)
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Prepublication document
The Draft Guidance |
Agency Information Collection Activities; Proposed Collection; Comment Request; Reporting and Recordkeeping Requirements
for Mammography Facilities; Correction. (26JUL00)
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Prepublication document |
Medical Devices; Draft Guidance for Surveillance and Detention Without Physical Examination of Surgeons' and/or Patient
Examination Gloves; Availability. (26JUL00)
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Prepublication document
The Draft Guidance |
Medical Devices; CLIA Waiver Criteria; Public Workshop. (21JUL00)
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Prepublication document |
Amendment of Various Device Regulations to Reflect Current American Society for Testing and Materials Citations;
Confirmation in Part and Technical Amendment. (18JUL00)
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Prepublication document |
Compliance Guidance: The Mammography Quality Standards Act Final Regulations Document #3; Availability. (18JUL00)
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Prepublication document
The Guidance |
Guidance for Industry and FDA Reviewers on Medical Device Use--Safety: Incorporating Human Factors Engineering into Risk
Management; Availability.18JUL00)
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Prepublication document
The Guidance |
Medical Devices; Draft Guidance for Staff, Industry, and Third Parties Implementation of Third Party Programs Under the
FDA Modernization Act of 1997; Availability. (18JUL00)
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Prepublication document
The Draft Guidance |
Medical Devices; Exemptions From Premarket Notification; Class II Devices: Triiodothyronine Test System. (11JUL00)
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Prepublication document |
Wireless Technology Research; Effects of Radiofrequency Energy on Micronucleus Formation; Public Meeting. (10JUL00)
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Prepublication document |
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Investigational Device Exemptions,
Reports, and Records. (06JUL00)
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Prepublication document |
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Administrative Detention and Banned
Medical Devices; Correction. (06JUL00)
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Prepublication document |
Medical Devices; Effective Date of Requirement for Premarket Approval for a Class III Preamendments Obstetrical and
Gynecological Device. (05JUL00)
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Prepublication document |
Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting. (05JUL00)
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Prepublication document |
Ear, Nose, and Throat Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting. (05JUL00)
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Prepublication document |
Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting. (27JUN00)
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Prepublication document |
Medical Imaging Drugs Advisory Committee; Notice of Meeting. (26JUN00)
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Prepublication document |
Medical Devices; Anesthesiology Devices; Classification of Devices to Relieve Upper Airway Obstruction. (23JUN00)
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Prepublication document |
Agency Information Collection Activities; Proposed Collection; Comment Request; Extension; Latex Condoms; User Labeling;
Expiration Dating. (23JUN00)
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Prepublication document |
Agency Information Collection Activities; Proposed Collection; Comment Request; Export of Medical Devices_Foreign Letters
of Approval. (20JUN00)
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Prepublication document |
Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting. (15JUN00)
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Prepublication document |
General Hospital and Personal Use Devices; Classification of the Subcutaneous, Implanted, Intravascular Infusion Port and
Catheter and the Percutaneous, Implanted, Long-term Intravascular Catheter. (13JUN00)
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Prepublication document |
Agency Information Collection Activities: Proposed Collection; Comment Request; Agreement for Shipment of Devices for
Sterilization. (12JUN00)
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Prepublication document |
Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications. (12JUN00)
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Prepublication document |
General Hospital and Personal Use Devices; Classification of Liquid Chemical Sterilants/High Level Disinfectants and
General Purpose Disinfectants. (08JUN00)
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Prepublication document |
Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting. (08JUN00)
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Prepublication document |
Technical Electronic Product Radiation Safety Standards Advisory Committee; Notice of Meeting. (08JUN00)
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Prepublication document |
Agency Information Collection Activities; Proposed Collection; Comment Request; Reporting and Recordkeeping Requirements
and Availability of Sample Electronic Products for Manufacturers and Distributors of Electronic Products. (05JUN00)
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Agency Information Collection Activities; Announcement of OMB Approval; Application for Exemption From Federal Preemption
of State and Local Medical Device Requirements. (01JUN00)
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Prepublication document
Supporting Statement
|
Obstetrical and Gynecological Devices; Classification of Female Condoms. (18MAY00)
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Prepublication document |
State Certification of Mammography Facilities; Correction. (05MAY00)
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Medical Devices; Device Tracking. (25APR00)
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Prepublication document |
General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting. (20APR00)
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Prepublication document |
Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting. (20APR00)
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Prepublication document |
Medical Devices; Reclassification of 38 Preamendments Class III Devices into Class II. (19APR00)
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Prepublication document |
Guidance Documents for Premarket Notification (510(k)) Submissions for Six Devices; Availability. (19APR00)
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Prepublication document
The Guidance for 00D-1086
The Guidance for 00D-1087
The Guidance for 00D-1088
The Guidance for 00D-1089
The Guidance for 00D-1090
he Guidance for 00D-1091 |
Medical Devices; Reclassification and Codification of the Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture.
(18APR00)
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Prepublication document |
Medical Devices; Effective Date of Requirement for Premarket Approval for Three Preamendment Class III Devices.
(13APR00)
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Prepublication document |
Medical Devices; Reclassification and Codification of the Stainless Steel Suture. (13APR00)
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Prepublication document |
Agency Information Collection Activities; Proposed Collection; Comment Request; Investigational Device Exemptions,
Reports, and Records. (13APR00)
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Prepublication document |
DOCKET , OC00, "Agency Information Collection Activities; Announcement of OMB Approval; Reporting and Recordkeeping
Requirements for Manufacturers, Importers, User Facilities, and Distributors of Medical Devices Under FDAMA. (13APR00)
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Prepublication document
Supporting Statement |
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Application for Exemption From
Federal Preemption of State and Local Medical Device Requirements. (13APR00)
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Prepublication document |
Gastroenterology-Urology Devices; Effective Date of Requirement for Premarket Approval of the Penile Inflatable Implant.
(12APR00)
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Prepublication document |
Cardiovascular, Orthopedic, and Physical Medicine Diagnostic Devices; Reclassification of Cardiopulmonary Bypass Accessory
Equipment, Goniometer Device, and Electrode Cable Devices. (11APR00)
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Prepublication document |
Hematology and Pathology Devices; Reclassification; Restricted Devices; OTC Test Sample Collection Systems for Drugs of
Abuse Testing. (07APR00)
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Prepublication document |
Medical Devices; Laser Fluorescence Caries Detection Device. (07APR00)
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Prepublication document |
Medical Devices; Gastroenterology_Urology Devices; Nonimplanted, Peripheral Electrical Continence Device. (07APR00)
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Prepublication document |
Medical Devices; Information Processing Procedures; Obtaining, Submitting, Executing, and Filing of Forms: Change of
Addresses. (31MAR00)
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Prepublication document |
Draft Guidance for Industry on Information Program on Clinical Trials for Serious or Life-Threatening Diseases:
Establishment of a Data Bank; Availability. (29MAR00)
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Prepublication document
The Draft Guidance |
Reclassification of 28 preamendments class III devices into class II. (31MAR00)
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Prepublication document |
Agency Information Collection Activities: Proposed Collection; Comment Request; Administrative Detention and Banned
Medical Devices. (31MAR00)
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Prepublication document |
Medical Devices Regulated by the Center for Biologics Evaluation and Research; List of Premarket Approval Actions.
(31MAR00)
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Prepublication document |
State Certification of Mammography Facilities. (30MAR00)
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Prepublication document |
Medical Devices; Availability of Safety and Effectiveness Summaries for PMA. (30MAR00)
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Prepublication document |
Clinical Chemistry Devices; Classification of the Biotinidase Test System. (29MAR00)
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Prepublication document |
Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting. (28MAR00)
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Prepublication document |
Neurological Devices Panel Advisory Committee; Notice of Meeting. (15MAR00)
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Prepublication document |
Food and Drug Administration/Industry Exchange Workshop on Medical Device Quality Systems Inspection Technique (QSIT);
Public Workshops; Addendum. (10MAR00)
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Prepublication document |
Microbiology Devices; Reclassification of Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility Devices
From Class III to Class II. (08MAR00)
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Prepublication document |
Draft Guidance on Review Criteria for Assessment of Antimicrobial Susceptibility Devices; Availability. (08MAR00)
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Prepublication document
The Draft Guidance |
Orthopedic Devices; Reclassification of the Knee Joint Patellofemorotibial Metal/Polymer Porous-Coated Uncemented
Prosthesis and the Knee Joint Femorotibial (Uni-compartmental) Metal/Polymer Porous-Coated Uncemented Prosthesis. (07MAR00)
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Medical Devices; Anesthesiology Devices: Classification of Nitric Oxide Administration Apparatus, Nitric Oxide Analyzer,
and Nitrogen Dioxide Analyzer. (03MAR00)
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Prepublication document |
Medical Devices; Exemptions from Premarket Notification; Class II Devices; Vascular Tunnelers. (03MAR00)
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Prepublication document |
Draft Guidance for Industry; Guidance on Medical Device Patient Labeling; Availability. (03MAR00)
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Prepublication document
The Draft Guidance |
Medical Device Quality Systems Inspection Technique; Notice of Workshop. (28FEB00)
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Prepublication document |
Medical Devices; Hearing Aids; Technical Data Amendments; Confirmation of Effective Date. (25FEB00)
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Prepublication document |
Compliance Guidance: The Mammography Quality Standards Act Final Regulations Document 1B2 (25FEB00)
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Prepublication document
The Guidance |
Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting. (23FEB00)
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Prepublication document |
Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee; Notice of
Meeting. (23FEB00)
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Prepublication document |
General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting. (22FEB00)
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Prepublication document
The Draft Guidance |
Orthopedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting. (17FEB00)
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Prepublication document |
Agency Information Collection Activities; Announcement of OMB Approval; Reclassification Petitions for Medical
Devices. (10FEB00)
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Prepublication document
Supporting Statement |
Gastroenterology-Urology Devices: Reclassification of the Penile Rigidity Implant. (02FEB00)
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Prepublication document |
Medical Devices; Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to
Support Reconsideration of Postmarket Surveillance Requirements; Availability. (02FEB00)
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Prepublication document
The Guidance |
Draft Guidance on Reprocessing and Reuse of Single-Use Devices: Risk Categorization Scheme; Availability. (02FEB00)
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Prepublication document
The Guidance |
Medical Device Reporting: Manufacturer Reporting, Importer Reporting, User Facility Reporting, Distributor
Reporting. (26JAN00)
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Prepublication document |
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Reporting and Recordkeeping
Requirements for Manufacturers, Importers, User Facilities, and Distributors of Medical Devices Under FDAMA. (26JAN00)
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Prepublication document |
Amendment of Various Device Regulations to Reflect Current American Society for Testing and Material Citations. (24JAN00)
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Prepublication document |
Amendment of Various Device Regulations to Reflect Current American Society for Testing and Materials Citations; Companion
Document to Direct Final Rule. (24JAN00)
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Prepublication document |
FDA Modernization Act of 1997; Guidance on Medical Device Tracking; Availability. (24JAN00)
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Prepublication document
The Guidance |
Medical Devices; Guidance Document for Premarket Notification Submissions for the Nitric Oxide Delivery Apparatus, Nitric
Oxide Analyzer, and Nitrogen Dioxide Analyzer; Availability". (24JAN00)
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Prepublication document
The Guidance |
Approval of an Alternate Requirement of the User Labeling Requirements for Devices Containing Dry Natural Rubber that
Contact Humans; Availability. (21JAN00)
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Prepublication document |
Guidance for Industry: Alternative to Certain Prescription Device Labeling Requirements; Availability. (21JAN00)
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Prepublication document |
Agency Information Collection Activities; Proposed Collection; Comment Request; Application for Exemption From Federal
Preemption of State and Local Medical Device Requirements. (18JAN00)
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Prepublication document |
Agency Information Collection Activities; Announcement of OMB Approval;Quality Mammography Standards Lay Summaries for
Patients. (18JAN00)
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Prepublication document
Supporting Statement |
Agency Information Collection Activities; Announcement of OMB Approval; Medical Device Recall Authority. (18JAN00)
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Prepublication document
Supporting Statement |
Agency Information Collection Activities; Announcement of OMB Approval; Medical Devices Humanitarian Use Devices. (18JAN00)
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Prepublication document
Supporting Statement |
Medical Devices; Exemption From Premarket Notification and Reserved Devices; Class I. (14JAN00)
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Prepublication document |
Medical Devices; Revocation of Exemptions from Premarket Notification for Certain Cardiovascular and Physical Medicine
Devices. (14JAN00)
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Prepublication document |
Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting. (14JAN00)
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Prepublication document
The Guidance |
National Mammography Quality Assurance Advisory Committee; Notice of Meeting. (06JAN00)
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Prepublication document
The Guidance |
General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting. (03JAN00)
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Prepublication document |
