Radiological Devices Panel Advisory Meeting, March 4-5, 2008 - Transcripts

Tue, 13 May 2008
On March 4 and 5, 2008, the committee intends to discuss and make recommendations about computer aided detection and diagnosis (CAD) devices for radiological images, e.g., mammograms, chest x-rays, and computed tomography (CT) images of the lungs or ...
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Ophthalmic Devices Panel Advisory Meeting, April 24-25, 2008 - Slides

Thu, 08 May 2008
On April 24, 2008, the committee will discuss, make recommendations, and vote on a premarket approval application, sponsored by VisionCare Technologies, Inc., for an implantable miniature telescope (IMT™). The IMT™, a visual prosthetic device, is in...
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PMA Final Decisions for April 2008

Thu, 08 May 2008
These are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions for April 2008.
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Summary Information for: Thoratec HeartMate II® Left Ventricular Assist System (LVAS)

Wed, 07 May 2008
PDF format only. Topics: Ventricular Assist Device
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Guidance for Industry and FDA Staff: Administrative Procedures for CLIA Categorization

Tue, 06 May 2008
This guidance document describes the general administrative procedures FDA will use to categorize tests under CLIA. This guidance does not specifically address CLIA waiver applications.
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Consumer Information on: Thoratec HeartMate II LVAS - P060040

Tue, 06 May 2008
The HeartMate II LVAS is a left ventricular assist device (LVAD) system; a device that helps the heart?s left ventricle (the main pumping chamber of the heart) deliver blood to the rest of the body. The HeartMate II LVAS includes...
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510(k) Final Decisions - April 2008

Mon, 05 May 2008
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Federal Register: Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting.

Thu, 01 May 2008
The committee will discuss, make recommendations and vote on a premarket approval application for the ProGEL Surgical Sealantsponsored by NeoMend, Inc.
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Federal Register: Towards an Artificial Pancreas: A Food and Drug Administration, National Institutes of Health, Juvenile Diabetes Research Foundation Public Workshop.

Wed, 30 Apr 2008
The FDA, in collaboration with the National Institutes of Health (NIH) and the Juvenile Diabetes Research Foundation (JDRF), is holding a public workshop focused upon the state of the art in the research and development of an artificial pancreas. The...
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Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Additional Listing Information for Medical Device Registration and Listing.

Wed, 30 Apr 2008
The FDA is is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of...
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Federal Register: Dental Devices: Classification of Encapsulated Amalgam Alloy and Dental Mercury and Reclassification of Dental Mercury; Issuance of Special Controls for Amalgam Alloy; Reopening of Comment Period.

Mon, 28 Apr 2008
The FDA is reopening for 90 days, the comment period for the proposed rule, published in the Federal Register of February 20, 2002 (67 FR 7620), on the classification of encapsulated amalgam alloy and dental mercury, the reclassification of dental...
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FDA Clears Glove Made from New Type of Latex

Fri, 25 Apr 2008
The U.S. Food and Drug Administration has cleared for marketing the first device made from a new form of natural rubber latex, guayule latex. The product, the Yulex Patient Examination Glove, is derived from the guayule bush, a desert plant native to...
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Summary Information for: CONTAK RENEWAL® 3 AVT® Models M150, M155, M157 and M159

Thu, 24 Apr 2008
PDF format only. Topics: Implantable Cardioverter Defibrillator
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Federal Register: Draft Guidance for Industry on Developing Coronary Drug Eluting Stents: Public Workshop.

Thu, 24 Apr 2008
The FDA is announcing a public workshop entitled 'Coronary Drug-Eluting Stent (DES) Guidance Document Workshop.' FDA is cosponsoring the workshop with the Advanced Medical Technology Association (AdvaMed). The purpose of the workshop is to discuss the...
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Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Labeling Regulations.

Thu, 24 Apr 2008
announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each...
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Guidance for Industry and FDA Staff: Hemodialysis Blood Tubing Sets - Premarket Notification [510(k)] Submissions (Updated 4/24/2008)

Thu, 24 Apr 2008
This guidance document is intended to assist industry in preparing an Abbreviated premarket notification submission (510(k)) to establish that the device is substantially equivalent to a predicate hemodialysis blood tubing set for use as the...
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Federal Register: Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Notice of Postponement of Meeting.

Thu, 24 Apr 2008
The FDA is postponing the meeting of the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee scheduled for May 16, 2008. The meeting was announced in the Federal Register of March 27, 2008 (73 FR 16315). FDA's Center for...
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Summary Information for: Talent™ Abdominal Stent Graft System

Thu, 24 Apr 2008
PDF format only. Topics: Stents
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Federal Register: Agency Information Collection Activites; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Device Tracking.

Tue, 22 Apr 2008
The FDA is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection...
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Federal Register: Draft Guidance for Sponsors, Industry, Researchers, Investigators, and Food and Drug Administration Staff: Certifications to Accompany Drug, Biological Product, and Device Applications/Submissions: Compliance With Section 402(j)

Fri, 18 Apr 2008
The FDA is announcing the availability of a draft guidance for industry entitled 'Guidance for Sponsors, Industry, Researchers, Investigators, and FDA Staff: Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions:...
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Guidance for Industry and FDA Staff: Investigational Device Exemptions (IDEs) for Devices Indicated for Nocturnal Home Hemodialysis

Fri, 18 Apr 2008
FDA has developed this guidance document to assist industry in preparing Investigational Device Exemption (IDE) applications for nocturnal home hemodialysis (NHHD) systems. These dialysis devices are intended to administer dialysis therapy in the home...
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Guidance for Industry and FDA Staff: Preparation and Review of Investigational Device Exemption Applications (IDEs) for Total Artificial Discs

Fri, 18 Apr 2008
This document was developed to describe our recommendations for IDE applications for total artificial disc devices. It provides guidance for developers on the appropriate pre-clinical tests and clinical trial designs to adequately evaluate the safety...
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Consumer Information on: Talent™ Abdominal Stent Graft System - P070027

Thu, 17 Apr 2008
The Talent™ Abdominal Stent Graft System is used to repair aneurysms of the aorta in the abdomen (belly). An aneurysm is a diseased, weakened and bulging section of an artery wall. The Talent™ Abdominal Stent Graft System is made of a fabric...
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