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Acetylcysteine Solution, USP (Roxane Laboratories, Inc.): Recall - Visible Glass Particle

February 3, 2012 5:30 am | by U.S. Food & Drug Administration | News | Comments

Use of an inhaled product with glass particles has the potential to cause choking which could be life-threatening.

Summary Information for: Therapy Cool Path Duo? Ablation Catheter, Safire BLU Duo? Ablation Catheter, and IBI1500T9-CP V1.6 Cardiac Ablation Generator

February 2, 2012 11:31 am | by U.S. Food & Drug Administration | News | Comments

Labeling, Approval Order, and Summary of Safety and Effectiveness for Therapy Cool Path Duo? Ablation Catheter, Safire BLU Duo? Ablation Catheter, and IBI1500T9-CP V1.6 Cardiac Ablation Generator (P110016).

Consumer Information on: Therapy Cool Path Duo? Ablation Catheter, Safire BLU Duo? Ablation Catheter, and IBI1500T9-CP V1.6 Cardiac Ablation Generator - P110016

February 2, 2012 11:30 am | by U.S. Food & Drug Administration | News | Comments

The Therapy Cool Path Duo? Ablation Catheter or the Safire BLU Duo? Ablation Catheter is a steerable, deflectable, irrigated catheter (a long, thin, flexible tube) used to treat a certain kind of abnormal heart rhythm (arrhythmia2) called typical atrial..

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Extended Sunshine Act Deadline Provides Extra Time for Pharma, Biotech and Device Companies to Track and Report Physician Payments

February 1, 2012 5:56 am | News | Comments

RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--As the industry awaits the release of the delayed Sunshine Act guidelines, pharmaceutical and medical device companies are benefiting from the extra time by reviewing current physician payment reporting structures...

FDA and industry reach agreement in principle on medical device user fees

February 1, 2012 5:12 am | News | Comments

The FDA and representatives from the medical device industry have reached an agreement in principle on proposed recommendations for the third reauthorization of a medical device user fee program. The recommendations would authorize the FDA to collect $595 million in user fees...

Lo/Ovral-28 (Norgestrel/EthinylEstradiol) Tablets: Recall - Possibility of Inexact Tablet Counts or Out of Sequence Tablets

February 1, 2012 4:30 am | by U.S. Food & Drug Administration | News | Comments

Oral contraceptive daily regimen may be incorrect and could leave women without adequate contraception, and at risk for unintended pregnancy.

Vitaflo USA Renastart: Recall - Possible Health Risk Due To Incorrectly Labeled Cans

January 31, 2012 8:30 am | by U.S. Food & Drug Administration | News | Comments

Consequences of using the incorrectly labeled product may result in high potassium blood levels (hyperkalemia) or high sodium levels in the blood (hypernatremia).

Treanda (bendamustine HCL): Recall - Particulate Matter in Vial

January 30, 2012 4:30 am | by U.S. Food & Drug Administration | News | Comments

Potential adverse events after intravenous administration of solutions containing particulates may include emboli and result in disruption of blood flow, causing tissue/organ damage.

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CDRH: Priorities This Year Include Product Lifecycle, Helping Innovation

January 27, 2012 1:31 pm | by U.S. Food & Drug Administration | News | Comments

CDRH’s 2012 priorities include a strong focus on innovation and the device approval process, a strategic report shows.

Congressional Democrats Call for Hearings on Hazardous Medical Devices

January 27, 2012 1:30 pm | by U.S. Food & Drug Administration | News | Comments

House Democrats are urging the Committee on Energy and Commerce to hold hearings on whether the FDA and device industry are doing all they can to protect consumers from unsafe products.

Consumer Information on: M-Vu Algorithm Engine - P100005

January 27, 2012 11:31 am | by U.S. Food & Drug Administration | News | Comments

The M-Vu Algorithm Engine is a software application designed to process digitized film images of the breast. The software analyzes the images and marks suspicious areas consistent with breast cancer for review by a radiologist. The results are displayed o

Summary Information for: M-Vu Algorithm Engine

January 27, 2012 11:30 am | by U.S. Food & Drug Administration | News | Comments

Labeling, Approval Order, and Summary of Safety and Effectiveness for M-Vu Algorithm Engine (P100005).

Summary Information for: MelaFind & #xae;

January 25, 2012 7:30 am | by U.S. Food & Drug Administration | News | Comments

Labeling, Approval Order, and Summary of Safety and Effectiveness for MelaFind® (P090012).

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Suspension Orthopaedics Gets FDA Clearance for Surgical System

January 25, 2012 5:23 am | News | Comments

ARNOLD, MD - Suspension Orthopaedic Solutions announced it has received FDA 510(k) clearance for two new products - its Distal Clavicle Fracture Fixation Systemâ„¢ and a new plate designed to address repair of mid-shaft clavicle fractures. The new Distal Clavicle Fracture Fixation System features...

Consumer Information on: ADVIA & #xae; Centaur Anti-HBs2 (aHBs2) Assay and ADVIA & #xae; Centaur Anti-HBs2 (aHBs2) Quality Control Material for use on the ADVIA & #xae; Centaur and ...

January 24, 2012 3:31 am | by U.S. Food & Drug Administration | News | Comments

ADVIA Centaur Anti-HBs2 (aHBs2) assay is a laboratory test used to detect antibodies associated with hepatitis B virus (HBV) infection.

Summary Information for: ADVIA & #xae; Centaur Anti-HBs2 (aHBs2) Assay and ADVIA & #xae; Centaur Anti-HBs2 (aHBs2) Quality Control Material for use on the ADVIA & #xae; Centaur and ...

January 24, 2012 3:30 am | by U.S. Food & Drug Administration | News | Comments

Labeling, Approval Order, and Summary of Safety and Effectiveness for ADVIA® Centaur Anti-HBs2 (aHBs2) Assay and ADVIA® Centaur Anti-HBs2 (aHBs2) Quality Control Material for use on the ADVIA® Centaur and ADVIA® Centaur XP Systems (P100039).

Premarket Approval (PMA) Summary Review Memos for 180-Day Design Changes (New Memos Available).

January 23, 2012 3:31 am | by U.S. Food & Drug Administration | News | Comments

A 180-day supplement is a request for a significant change in components, materials, design, specification, software, color additive, and labeling to an approved premarket application or premarket report.

Tysabri (natalizumab): Drug Safety Communication - New Risk Factor for Progressive Multifocal Leukoencephalopathy (PML)

January 20, 2012 1:30 pm | by U.S. Food & Drug Administration | News | Comments

The risks and benefits of continuing treatment with Tysabri should be carefully considered in patients who are found to be anti-JCV antibody positive and have one or more of the other known risk factors for PML.

Perfect Image Solutions Topical Hair Regrowth Products: Recall - Unapproved Drugs, Risk of Health Hazards

January 20, 2012 10:30 am | by U.S. Food & Drug Administration | News | Comments

Systemic absorption of topically administered Minoxidil could cause low blood pressure, heart palpitations and associated cardiac symptoms.

Vagifresh Ball, Vagifresh Gel, Female One: Recall - Undeclared Drug Ingredient, Bacterial Contamination

January 20, 2012 9:30 am | by U.S. Food & Drug Administration | News | Comments

Possibility of an adverse reaction or unknown drug-drug interaction.

Consumer Information on: GORE TAG Thoracic Endoprosthesis - P040043/S040

January 19, 2012 5:31 am | by U.S. Food & Drug Administration | News | Comments

The GORE TAG Thoracic Endoprosthesis is an artificial endovascular stent graft and is used to treat isolated lesions, excluding dissections, of the descending thoracic aorta during endovascular repair. Some of the complex isolated lesions include...

Summary Information for: GORE TAG Thoracic Endoprosthesis

January 19, 2012 5:30 am | by U.S. Food & Drug Administration | News | Comments

Labeling, Approval Order, and Summary of Safety and Effectiveness for GORE TAG Thoracic Endoprosthesis (P040043S040).

Interstate Specialty Products Receives ISO 13485 Certification

January 19, 2012 4:51 am | News | Comments

Sutton, MA – Interstate Specialty Products, Inc., a manufacturer of high performance custom gaskets and provider of custom die-cutting services, recently received ISO 13485 certification for their quality management system. ISO 13485 is an international standard thatspecifies requirements...

Grifols Receives ISO 13485:2003+AC:2009 Quality Management Certification for its Medical Devices

January 18, 2012 4:50 am | News | Comments

LOS ANGELES/PRNewswire/ -- Grifols, a global healthcare company and biopharmaceutical manufacturer based in Barcelona, Spain, announced that its U.S. diagnostic and hospital divisions have received ISO 13485:2003+AC:2009 certification, an international quality standard...

Evaluation of Automatic Class III Designation (De Novo) Decision Summaries: K102333 added

January 14, 2012 9:31 am | by U.S. Food & Drug Administration | News | Comments

The Food and Drug Administration Modernization Act of 1997 (FDAMA) added the "De Novo" classification option as an alternate pathway to classify certain new devices that had automatically been placed in Class III due to lack of a predicate.

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