Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting. (26DEC01)
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Medical Devices; Guidance on Labeling of Reprocessed Single Use Devices; Request for Comments and Information. (20DEC01)
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Medical Devices: Draft Guidance on Cardiac Ablation Catheters Generic Arrhythmia Indications for Use; Availability.
(07DEC01)
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The Draft Guidance
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Medical Devices; Class II Special Controls Guidance Document: Indwelling Blood Gas Analyzers; Final Guidance for Industry
and FDA; Availability. (15NOV01)
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The Guidance |
Medical Devices; Reclassification of Three Anesthesiology Preamendments Class III Devices into Class II. (15NOV01)
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Medical Devices; Exemptions From Premarket Notification; Class II Devices. (15NOV01)
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Annual Comprehensive List of Guidance Documents at the Food and Drug Administration. (24OCT01)
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The List
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Electronic Interchange Standard for Digital ECG and Similar Data; Public Meeting. (24OCT01)
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Agency Information Collection Activities; Announcement of OMB Approval; Premarket Notification 510(k) Submissions.
(23OCT01)
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Supporting Statement |
Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting. (23OCT01)
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Agency Information Collection Activities; Announcement of OMB Approval; Survey of Single-Use Medical Device Reuse and
Reprocessing in Hospitals. (22OCT01)
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Supporting Statement |
Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting.
(17OCT01)
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Agency Information Collection Activities; Submission for OMB Review; Comment Request; Medical Device Registration and
Listing. (16OCT01)
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Prepublication display |
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Medical Device Labeling Regulations.
(16OCT01)
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Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Third-Party Premarket
Submission Review and Quality System Inspections Under United States/European Community Mutual Recognition Agreement.
(05OCT01)
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Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting. (27SEP01)
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Medical Devices; Exemption From Premarket Notification Requirements; Class I Devices (Final rule; technical amendment).
(10SEP01)
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Orthopedic and Rehabilitation Devices: Reclassification of the Hip Joint Metal/Polymer Constrained Cemented or Uncemented
Prosthesis. (06SEP01)
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Medical Devices; Draft Guidance; Class II Special Controls Guidance Document: Hip Joint Metal/Polymer Constrained Cemented
or Uncemented Prosthesis; Availability.
(06SEP01)
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The Draft Guidance |
Draft Multi-Agency Radiological Laboratory Analytical Protocols Manual (31AUG01)
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The Draft Guidance |
Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting. (27AUG01)
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Medical Devices Dispute Resolution Panel of the Medical Devices Advisory Committee. (24AUG01)
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CDRH 19995. Ear, Nose, and Throat Devices; Reclassification of Endolymphatic Shunt Tube With Valve. (15AUG01)
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Medical Devices: Draft Guidance on "Class II Special Control Guidance Document: Endolymphatic Shunt Tube With Valve; Draft
Guidance for Industry and FDA;" Availability.
(15AUG01)
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The Draft Guidance |
Agency Information Collection Activities; Announcement of OMB Approval; Premarket Approval of Medical Devices. (14AUG01)
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Medical Devices; Guidance for Saline, Silicone Gel, and Alternative Breast Implants; Final Guidance for Industry;
Availability. (13AUG01)
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The Guidance
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Draft Guidance for FDA Reviewers: Premarket Notification Submissions for Automated Testing Instruments Used in Blood
Establishments; Availability. (03AUG01)
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The Draft Guidance |
Laser Products-Conformance with IEC 60825-1, Am.2 and IEC 60601-2-22; Final Guidance for Industry and FDA (Laser Notice
50); Availability. (26JUL01)
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The Guidance |
Orthopedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting. (26JUL01)
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Medical Devices; A Pilot Program to Evaluate a Proposed Globally Harmonized Alternative for Premarket Procedures; Draft
Guidance for Industry and FDA Staff; Availability. (25JUL01)
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The Draft Guidance |
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Survey of Single-Use Medical Device
Reuse and Reprocessing in Hospitals. (25JUL01)
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Medical Devices; Exemption from Premarket Notification Requirements; Class I Devices; Technical Amendment. (25JUL01)
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Hematology and Pathology Devices; Reclassification of Automated Differential Cell Counters; Correction. (23JUL01)
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Agency Information Collection Activities; Announcement of OMB Approval; Adverse Event Pilot Program for Medical Devices.
(23JUL01)
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Supporting Statement
Attachment A
Attachment B |
Agency Information Collection Activities; Announcement of OMB Approval; Medical Devices; Current Good Manufacturing
Practice (CGMP), Quality System (QS) Regulation.
(20JUL01)
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Supporting Statement |
Medical Devices; Availability of Information Given to Advisory Committee Members in Connection with CDRH Open Public Panel
Meetings; Draft Guidance for Industry and FDA Staff; Availability. (18JUL01)
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The Draft Guidance |
Agency Information Collection Activities; Submission of OMB Review; Comment Request; Premarket Notification 510(k)
Submissions. (18JUL01)
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Subcommittee for the Center for Devices and Radiological Health Science Review of the Science Board to the Food and Drug
Administration; Notice of Meeting. (17JUL01)
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National Mammography Quality Assurance Advisory Committee; Notice of Meeting. (13JUL01)
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Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices Labeling Regulations.
(11JUL01)
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Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Agency Information
Collection Activities; Proposed Collection; Comment Request; Reports of Corrections and Removals. Registration and Listing. (06JUL01)
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Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications. (06JUL01)
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Medical Devices; Guidance on Resolving Scientific Disputes Concerning the Regulation of Medical Devices; Availability.
(02JUL01)
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The Guidance |
CDRH 200144. Workshop on Preclinical Testing for Endovascular Grafts. (02JUL01)
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General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee. (28JUN01)
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Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee. (28JUN01)
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Medical Devices Premarket Guidance: Reprocessing and Reuse of Single-Use Devices; Draft Guidance for Industry and FDA
Staff; Availability; Correction. (26JUN01)
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Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting. (22JUN01)
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Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting. (21JUN01)
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Agency information collection activities; submission for OMB review; comment request; adverse event pilot program for
medical devices and blood products (20JUN01)
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Medical Devices; Exemptions From Premarket Notification; Class II Devices ([PRE-PUB} and (TXT) documents are set up to
accept electronic comments). (18JUN01)
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Medical Devices Premarket Guidance: Reprocessing and Reuse of Single-Use Devices; Draft Guidance for Industry and FDA
Staff; Availability (01JUN01)
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The Draft Guidance |
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Medical Devices; Current Good
Manufacturing Practice Quality System Regulation. (31MAY01)
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Medical Devices Dispute Resolution Panel of the Medical Devices Advisory Committee; Notice of Meeting. (30MAY01)
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Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Third-Party Review Under
FDAMA (29MAY01)
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Blood Products Advisory Committee, Medical Devices Panel; Reclassification of Autopheresis-c® System From Class III to
Class II (29MAY01)
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The Mammography Quality Standards Act Final Regulations Document #4; Final Guidance for Industry and FDA; Availability.
(23MAY01)
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The Guidance
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Orthopedic Devices: Classification and Reclassification of Pedicle Screw Spinal Systems; Technical Amendment. (22MAY01)
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Medical Devices: Draft Premarket Notifications [510(k)] for Biological Indicators Intended to Monitor Sterilizers Used in
Health Care Facilities; Draft Guidance for Industry and FDA Reviewers; Availability. (21MAY01)
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The Draft Guidance |
Clinical Development Programs for Drugs, Biological Products, and Devices for the Treatment of Ankylosing Spondylitis (AS)
and Related Disorders; Request for Assistance. (21MAY01)
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Medical Devices; Global Harmonization Task Force; Study Group 1; Working Draft "Medical Devices Classification;"
Availability. (16MAY01)
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Working Draft
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Agency Information Collection Activities; Submission for OMB Review; Comment Request; Premarket Approval of Medical
Devices. (16MAY01)
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Gastroenterology-Urology Devices; Classification of Tissue Culture Media for Human ex vivo Tissue and Cell Culture
Processing Applications. (16MAY01)
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The Guidance |
International Conference on Harmonisation; Choice of Control Group and Related Issues in Clinical Trials; Availability.
(14MAY01)
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The Guidance
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Hematology and Pathology Devices; Reclassification of Automated Differential Cell Counters. (09MAY01)
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OC 2001112. Agency Information Collection Activities; Announcement of OMB Approval; Request for Resolution of Scientific
Disputes Concerning the Regulation of Medical Devices. (09MAY01)
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Supporting Statement |
Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting. (09MAY01)
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pdf
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Agency Information Collection Activities; Announcement of OMB Approval; Use of Impact-Resistant Lenses in Eyeglasses and
Sunglasses. (06MAY01)
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Supporting Statement |
Medical Devices; Medical Device Reporting Regulations; Technical Amendment. (06MAY01)
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Medical Devices: Draft The Least Burdensome Provisions of the FDA Modernization Act of 1997: Concept and Principles;
Availability. (03MAY01)
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txt or pdf
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The Draft Guidance |
Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Notification 510(k)
Submissions. (30APR01)
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Agency Information Collection Activities; Proposed Collection; Comment Request; Survey of Single-Use Medical Devices Reuse
and Reprocessing in Hospitals. (30APR01)
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CDRH 20016. Neurological Devices; Reclassification of the Totally Implanted Spinal Cord Stimulator; Denial of Petition.
(30APR01)
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Technical Electronic Product Radiation Safety Standards Committee; Notice of Meeting. (30APR01)
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Draft Guidance for Industry; Premarket Approval Applications for In Vitro Diagnostic Devices Pertaining to Hepatitis C
Viruses (HCV); Assays Intended for Diagnosis, Prognosis, or Monitoring of HCV Infection, Hepatitis C, or Other HCV-Associated Disease; Availability. (27APR01)
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The Draft Guidance |
Medical Device Inspection Evaluation Report; Availability. (25APR01)
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The Guidance
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Guidance on Medical Device Patient Labeling; Availability. (19APR01)
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The Guidance |
Epidemiology Research Needs Related to the Radiofrequency Energy From Wireless Phones. (16APR01)
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Medical Devices; Reclassification of six Cardiovascular Preamendments Class III Devices into Class II. (10APR01)
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Medical Devices Draft Guidance for the Implementation of the Biomaterials Access Assurance Act of 1998;
Availability. (02APR01)
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The Draft Guidance |
Medical Devices; Information Disclosure by Manufacturers to Assemblers for Diagnostic X-Ray Systems; Availability.
(02APR01)
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The Guidance |
Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting. (02APR01)
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Hematology and Pathology Devices; Reclassification; Restricted Devices; OTC Test Sample Collection Systems for Drugs of
Abuse Testing; Delay of Effective Date. (30MAR01)
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Agency Information Collection Activities; Announcement of OMB Approval; Medical Devices; Classification/Reclassification;
Restricted Devices: Analyte Specific Reagents. (29MAR01)
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Guidance for Industry on Financial Disclosure by Clinical Investigators; Availability. (28MAR01)
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txt or pdf
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The Guidance |
Epidemiology Research Needs Related to the Radiofrequency Energy (RF) From Wireless Phones. (27MAR01)
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Medical Device; Exemption from Premarket Notification; Class II Devices; Pharmacy Compounding Systems.
(21MAR01)
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|
Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Premarket Approval of
Medical Devices; Correction. (20MAR01)
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Agency Information Collection Activities; Announcement of OMB Approval; Mammography Facilities, Standards, and Lay
Summaries for Patients;. (19MAR01)
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txt or pdf
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Supporting Statement |
Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications.
(12MAR01)
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Final Guidance for Industry and FDA Reviewers: Class II Special Controls Guidance for Home Uterine Activity Monitors;
Availability. (09MAR01)
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Medical Devices; Reclassification and Codification of Home Uterine Activity Monitor. (09MAR01)
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Medical Devices; Implementation of Third Party Programs Under the FDA Modernization Act of 1997; Final Guidance for Staff,
Industry and Third Parties; Availability. (08MAR01)
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The Guidance |
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Use of Impact-Resistant Lenses in
Eyeglasses and Sunglasses. (07MAR01)
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|
Medical Devices Draft Guidance for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Criteria for Waiver;
Availability. (01MAR01)
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The Draft Guidance |
Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Current Good
Manufacturing Practice Quality System Regulation (28FEB01)
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Clinical Chemistry and Clinical Toxicology Devices; Classification of B-Type Natriuretic Peptide Test System.
(28FEB01)
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Medical Devices; Reclassification of the Shoulder Joint Metal/Polymer/Metal Nonconstrained or Semi-Constrained
Porous-Coated Uncemented Prosthesis. (28FEB01)
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Agency Information Collection Activities; Proposed Collection; Comment Request; Adverse Event Pilot Program for Medical
Devices and Blood Products. (08FEB01)
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txt or pdf
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Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices;
Classification/Reclassification; Restricted Devices: Premarket Approval of Medical Devices. (08FEB01)
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Agency Information Collection Activities; Submission for OMB Review; Comment Request; Request for Resolution of Scientific
Disputes Concerning the Regulation of Medical Devices. (08FEB01)
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Devices - Inspections of Medical Device Manufacturers Compliance Program Guidance Manual, CP 7382.845; Availability.
(07FEB01)
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The Guidance |
Medical Devices; Rescission of Substantially Equivalent Decisions and Rescission Appeal Procedures. (16JAN01)
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Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting. (10JAN01)
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Agency Information Collection Activities; Submission for OMB Review; Comment Request; Medical Devices;
Classification/Reclassification; Restricted Devices: Analyte Specific Reagents. (05JAN01)
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Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting. (05JAN01)
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Expansion of Medical Devices Industry Initiatives. (04JAN01)
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