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Food and Drug Adminstration (FDA): CDRHNew
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Class I Medical Device Recall: Cook Medical, Inc., Zilver PTX Drug-Eluting Peripheral Stent
Reason for Recall: Cook Medical received a small number of complaints that the delivery system of the device had separated at the tip of the inner catheter. Potential adverse events that may occur in cases where the inner deliver catheter breakage...
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PMA Final Decisions for March 2013
These are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions for March 2013.
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Consumer Information on: SEDASYS® Computer-Assisted Personalized Sedation System - P080009
The SEDASYS System is a computer-assisted personalized sedation device that delivers the drug propofol for minimal-to-moderate sedation. The device provides comprehensive patient monitoring and limits the depth of sedation by adjusting drug delivery accor
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Meeting Announcement: June 26, 2013 General and Plastic Surgery Devices Panel of the Medical Devices Meeting Announcement
Meeting Announcement: June 26, 2013 General and Plastic Surgery Devices Panel of the Medical Devices Meeting Announcement
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Consumer Information on: Selenia Dimensions 3D System - P080003S001
The Selenia Dimensions System with the C-View Software Module is a mammography device that provides digital 2D and 3D images for the screening and diagnosis of breast cancer.
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Summary Information for: Selenia Dimensions 3D System
Labeling, Approval Order, and Summary of Safety and Effectiveness for Selenia Dimensions 3D System (P080003S001).
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Letter to Biosense Technologies Private Limited concerning the uChek Urine Analyzer
Letter to Biosense Technologies Private Limited concerning the uChek Urine Analyzer
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Federal Register: Cardiovascular Devices; Reclassification of External Counter-Pulsating Devices for Treatment of Chronic Stable Angina; Effective Date of Requirement for Premarket Approval for External Counter-Pulsating Devices for Other Specified Intended Uses
The FDA is issuing a proposed administrative order to reclassify external counter-pulsating (ECP) devices for treatment of chronic stable angina that is refractory to optimal anti-anginal medical therapy and without options for revascularization, which...
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Medical X-ray Imaging
Medical imaging has led to improvements in the diagnosis and treatment of numerous medical conditions in children and adults. There are many types - or modalities - of medical imaging procedures, each of which uses different technologies and...
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Fluoroscopy
Fluoroscopy is a type of medical imaging that shows a continuous X-ray image on a monitor, much like an X-ray movie. During a fluoroscopy procedure, an X-ray beam is passed through the body. The image is transmitted to a monitor so the movement of a...
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Class I Medical Device Recall: Abbott Diabetes Care, FreeStyle InsuLinx Blood Glucose Meters
At extremely high blood glucose levels of 1024 mg/dL and above, the FreeStyle InsuLinx Blood Glucose Meter will display and store in memory an incorrect test result that is 1024 mg/dL below the measured result. For example, at a blood glucose value of...
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Public Roster posted for May 21-22, 2013 Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting
Public Roster posted for May 21-22, 2013 Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting
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Transcript posted for April 25, 2013 Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee meeting
Transcript posted for April 25, 2013 Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee meeting
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Summary Information for: VASCADE Vascular Closure System (VCS)
Labeling, Approval Order, and Summary of Safety and Effectiveness for VASCADE Vascular Closure System (VCS) (P120016).
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Guidance for Industry and Food and Drug Administration Staff - Priority Review of Premarket Submissions for Devices
This document has the following purposes: (1) develop a common understanding of the statutory criteria for granting expedited review to premarket submissions for medical devices, and (2) outline standard procedures that should be followed to achieve an...
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Federal Register: Center for Devices and Radiological Health Appeals Processes; Guidance for Industry and FDA Staff; Availability
The FDA is announcing the availability of the guidance entitled 'Center for Devices and Radiological Health (CDRH) Appeals Processes.' This document describes the processes available to outside stakeholders to request additional review of decisions or...
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Summary Information for: cobas® EGFR Mutation Test
Labeling, Approval Order, and Summary of Safety and Effectiveness for cobas® EGFR Mutation Test (P120019).
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Consumer Information on: cobas® EGFR Mutation Test - P120019
The cobas® EGFR Mutation Test is an automated molecular assay designed to detect the presence of mutations in the epidermal growth factor receptor (EGFR) gene in cancer-spreading (metastatic) non-small cell lung cancer (NSCLC).
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Federal Register: Center for Devices and Radiological Health Appeals Processes: Questions and Answers About 517A; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The FDA is announcing the availability of the draft guidance entitled 'Center for Devices and Radiological Health (CDRH) Appeals Processes: Questions and Answers About 517A.' This draft document provides CDRH's proposed interpretation of key provisions of
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Meeting materials posted for May 21-22, 2013 Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting
Meeting materials posted for May 21-22, 2013 Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting
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Center for Devices and Radiological Health Appeals Processes - Guidance for Industry and Food and Drug Administration Staff
This guidance document describes the processes available to outside stakeholders to request additional review of decisions or actions by CDRH employees.
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Center for Devices and Radiological Health Appeals Processes: Questions and Answers About 517A - Draft Guidance for Industry and Food and Drug Administration Staff
This draft guidance document provides CDRH proposed interpretation of key provisions of Section 517A of the Food, Drug and Cosmetic Act (FD&C Act), which was added by section 603 of the FDA Safety and Innovation Act (FDASIA) of 2012, as those provisions..
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Federal Register: Medical Devices; General Hospital and Personal Use Monitoring Devices; Classification of the Ingestible Event Marker
The FDA classifying the ingestible event marker into class II (special controls). The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
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Federal Register: Dental Products Panel of the Medical Devices Advisory Committee; Notice of Meeting
This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Dental Products Panel of the Medical Devices Advisory Committee.
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Meeting Announcement: July 18, 2013 Dental Products Panel of the Medical Devices Advisory Committee
Meeting Announcement: July 18, 2013 Dental Products Panel of the Medical Devices Advisory Committee
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Transcript posted for April 8, 2013 Ophthalmic Devices Panel of the Medical Devices Advisory Committee Meeting
Transcript posted for April 8, 2013 Ophthalmic Devices Panel of the Medical Devices Advisory Committee Meeting
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Federal Register: Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are Not Individually Identifiable
The FDA is announcing that a collection of information entitled 'Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are Not Individually Identifiable' has been approved by the Office of Management and
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Federal Register: General and Plastic Surgery Devices: Reclassification of Ultraviolet Lamps for Tanning, Henceforth To Be Known as Sunlamp Products
The FDA is proposing to reclassify ultraviolet (UV) lamps intended to tan the skin from class I (general controls) exempt from premarket notification to class II (special controls) and subject to premarket notification, and to rename them sunlamp products
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Meeting Announcement: June 13, 2013 Microbiology Devices Panel of the Medical Devices Advisory Committee
Meeting Announcement: June 13, 2013 Microbiology Devices Panel of the Medical Devices Advisory Committee
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Federal Register: 510(k) Device Modifications: Deciding When To Submit a 510(k) for a Change to an Existing Device; Public Meeting; Request for Comments
The FDA is announcing the public meeting entitled '510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device.' The focus of this meeting is FDA's interpretation of its regulations concerning when a modification made
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