Food and Drug Adminstration (FDA): CDRHNew at Regulatory Affairs Syndicator

Author Archive for Food and Drug Adminstration (FDA): CDRHNew

Summary Information for: FreeStyle Navigator® Continuous Glucose Monitoring System - P050020

Closed Published by Food and Drug Adminstration (FDA): CDRHNew March 31st, 2008 in Regulatory Affairs

PDF format only. Topics: Glucose Monitoring

Federal Register: The Essentials of Food and Drug Administration Medical Device Regulations: A Primer for Manufacturers and Suppliers; Public Seminar (Notice of public seminar).

Closed Published by Food and Drug Adminstration (FDA): CDRHNew March 31st, 2008 in Regulatory Affairs

The Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health and Office of Regulatory Affairs, in cooperation with AdvaMed’s Medical Technology Learning Institute, is announcing a series of three seminars on FDA medical device…

FDA Seeks Civil Penalties from Calif. Device Maker

Closed Published by Food and Drug Adminstration (FDA): CDRHNew March 28th, 2008 in Regulatory Affairs

The U.S. Food and Drug Administration (FDA) today announced it is seeking a 2.2 million dollar penalty against a California hearing aid manufacturer for violations of federal law, including manufacturing standards violations and the failure to notify the FDA of a change in an outside supplier or vendor, which may have exposed recipients of the devices to unnecessary health risks.

Federal Register: Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting.

Closed Published by Food and Drug Adminstration (FDA): CDRHNew March 26th, 2008 in Regulatory Affairs

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: Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory…

Federal Register: Global Harmonization Task Force, Study Group 4; Final Document; Availability.

Closed Published by Food and Drug Adminstration (FDA): CDRHNew March 25th, 2008 in Regulatory Affairs

The FDA is announcing the availability of a final document that has been prepared by Study Group 4 of the Global Harmonization Task Force (GHTF). This document represents a harmonized proposal and recommendation from Study Group 4 of the GHTF that may…

Guidance for Industry: Coronary Drug-Eluting Stents - Nonclinical and Clinical Studies (Companion Document)

Closed Published by Food and Drug Adminstration (FDA): CDRHNew March 25th, 2008 in Regulatory Affairs

This guidance is intended to be used as a companion document to the guidance Coronary Drug Eluting Stents ? Nonclinical and Clinical Studies, which provides recommendations to sponsors or applicants planning to develop, or to submit to FDA, a marketing…

Guidance for Industry: Coronary Drug-Eluting Stents? Nonclinical and Clinical Studies

Closed Published by Food and Drug Adminstration (FDA): CDRHNew March 25th, 2008 in Regulatory Affairs

This guidance is intended to provide recommendations to sponsors or applicants2 planning to develop, or to submit to FDA, a marketing application for a coronary drug eluting stent (DES). The guidance discusses the data and clinical studies needed to…

Federal Register: Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting.

Closed Published by Food and Drug Adminstration (FDA): CDRHNew March 23rd, 2008 in Regulatory Affairs

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: Ophthalmic Devices Panel of the Medical Devices Advisory Committee. General…

Mammography Facility Adverse Event and Action Report - 2007

Closed Published by Food and Drug Adminstration (FDA): CDRHNew March 20th, 2008 in Regulatory Affairs

Congress enacted the Mammography Quality Standards Act (MQSA) in 1992, marking the first time mammography facilities were required by the federal government to meet strict quality standards. The intent of MQSA is to assure the quality of mammography…

Summary Information for: Dako TOP2A FISH pharmDx™ Kit

Closed Published by Food and Drug Adminstration (FDA): CDRHNew March 19th, 2008 in Regulatory Affairs

PDF format only. Topics: In Vitro Diagnostics (IVD)

PMA Final Decisions for February 2008

Closed Published by Food and Drug Adminstration (FDA): CDRHNew March 18th, 2008 in Regulatory Affairs

These are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions for February 2008.

FDA Public Health Notification: Updated Data on Mortality Associated with the Medtronic AneuRx® Stent Graft System

Closed Published by Food and Drug Adminstration (FDA): CDRHNew March 17th, 2008 in Regulatory Affairs

This notification is to re-emphasize the need for continued surveillance of patients treated with endovascular grafts and to provide you with updated information on the mortality risks associated with the use of the AneuRx® Stent Graft System to…

Medical Devices Dispute Resolution Panel Advisory Meeting, April 19, 2007 - Minutes

Closed Published by Food and Drug Adminstration (FDA): CDRHNew March 17th, 2008 in Regulatory Affairs

The committee will discuss, make recommendations, and vote regarding a scientific dispute between the agency and Cardima Inc. related to the not-approvable determination for the premarket approval application (PMA) for the REVELATION� Tx Microcathete…

Radiological Devices Panel Advisory Meeting, March 4-5, 2008 - Brief Summary

Closed Published by Food and Drug Adminstration (FDA): CDRHNew March 6th, 2008 in Regulatory Affairs

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 …