Archive for the 'Medical Devices' Category

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Questions and Answers about using Personal Protective Equipment during Influenza Outbreaks, including Bird Flu (Avian Influenza)

Closed Published by Food and Drug Adminstration (FDA): CDRHNew November 21st, 2005 in Medical Devices

Topics: Disasters, Pandemic Flu

PMA Final Decisions Rendered for October 2005

Closed Published by Food and Drug Adminstration (FDA): CDRHNew November 21st, 2005 in Medical Devices

These are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions for October 2005.

FDA Workshop on Regulatory Process for Pediatric Mechanical Circulatory Support Devices (Ventricular Assist Devices), January 20, 2006

Closed Published by Food and Drug Adminstration (FDA): CDRHNew November 18th, 2005 in Medical Devices

Presentations and Transcript from the October 31 - November 1, 2005 Radiological Health Stakeholder Meeting

Closed Published by Food and Drug Adminstration (FDA): CDRHNew November 18th, 2005 in Medical Devices

Topics: Radiological Health Items

Applicability of the Performance Standard for High-Intensity Mercury Vapor Discharge Lamps (21 CFR 1040.30) - Guidance for Industry and FDA Staff

Closed Published by Food and Drug Adminstration (FDA): CDRHNew November 17th, 2005 in Medical Devices

Topics: Mercury Vapor Lamps

Federal Register: Environmental Assessment; Categorical Exclusions - Final Rule

Closed Published by Food and Drug Adminstration (FDA): CDRHNew November 15th, 2005 in Medical Devices

Summary Information for: Guardian RT - P980022s011

Closed Published by Food and Drug Adminstration (FDA): CDRHNew November 15th, 2005 in Medical Devices

ACRYSOF® Single-Piece Posterior Chamber Intraocular Lenses With Toric Optic, Models SA60T3, SA60T4 and SA60T5

Closed Published by Administrator November 15th, 2005 in Medical Devices

The ACRYSOF® Toric IOLs are artificial lenses implanted in the eye to restore vision after a clouded natural lens (cataract) is removed. (Approved: 9/14/2005)

Class I Medical Device Recalls: bioMérieux, Inc. VeriCal® Calibrator Sets

Closed Published by Administrator November 14th, 2005 in Medical Devices

Reason for Recall: The recalled lots of VeriCal® Calibrator Sets are mislabeled (the specific International Sensitivity Index (ISI) label values published in the packaging were mislabeled for the Multichannel Discrete Analyzer (MDA), Coag-a-Mate MAX and..

Federal Register: Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Labeling for Male Condoms Made of Natural Rubber Latex; Availability.

Closed Published by Food and Drug Adminstration (FDA): CDRHNew November 14th, 2005 in Medical Devices

This draft guidance document describes a means by which natural rubber latex (latex) condoms with and without spermicidal lubricant containing nonoxynol-9 (N-9) may comply with the requirement of special controls for class II devices. …

Federal Register: Obstetrical and Gynecological Devices; Designation of Special Control for Condom and Condom With Spermicidal Lubricant

Closed Published by Food and Drug Adminstration (FDA): CDRHNew November 14th, 2005 in Medical Devices

Blood Human Chorionic Gonadotropin (hCG) Assays: What Laboratorians Should Know about False-Positive Results

Closed Published by Food and Drug Adminstration (FDA): CDRHNew November 10th, 2005 in Medical Devices

The FDA has developed this communication in response to reports sent to FDA by manufacturers and users of hCG assays of adverse events associated with falsely elevated human chorionic gonadotropin (hCG) results.

Federal Register: Medical Devices; A Pilot Program to Evaluate a Proposed Globally Harmonized Alternative for Premarket Procedures; Guidance for Industry and FDA Staff; Availability.

Closed Published by Food and Drug Adminstration (FDA): CDRHNew November 10th, 2005 in Medical Devices

Labeling for Male Condoms Made of Natural Rubber Latex - Class II Special Controls Guidance Document - Draft Guidance for Industry and FDA Staff

Closed Published by Food and Drug Adminstration (FDA): CDRHNew November 10th, 2005 in Medical Devices

Topics: Condoms, Labeling, Latex Products

A Pilot Program to Evaluate a Proposed Globally Harmonized Alternative for Premarket Procedures; Guidance for Industry and FDA Staff

Closed Published by Food and Drug Adminstration (FDA): CDRHNew November 9th, 2005 in Medical Devices

Topics: Global Harmonization, Premarket Approval, Premarket Notification (510(k))

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