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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.

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.

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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).

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...

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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.

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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.

FDA Asks TV Mesh Manufacturers to Conduct Postmarket Studies

January 13, 2012 1:31 pm | by U.S. Food & Drug Administration | News | Comments

Surgical mesh manufacturers have until Feb. 3 to submit their plans to the FDA for conducting postmarket studies under Section 522 of the 1938 FD&C Act.

MDUFA Agreement Progresses, But Sticking Points Remain

January 13, 2012 1:31 pm | by U.S. Food & Drug Administration | News | Comments

FDA-industry negotiations to reauthorize the Medical Device User Fee Act (MDUFA) went down to the wire last week, as CDRH seemed destined to miss a Jan. 15 due date for sending a commitment letter to Congress.

Adcetris (brentuximab vedotin): Drug Safety Communication - Progressive Multifocal Leukoencephalopathy and Pulmonary Toxicity

January 13, 2012 7:31 am | by U.S. Food & Drug Administration | News | Comments

New Boxed Warning and Contraindication highlighting these risks added to product labeling.

Bedford Laboratories Polymyxin B For Injection USP And Vecuronium Bromide For Injection: Recall - Glass Particles

January 12, 2012 8:31 am | by U.S. Food & Drug Administration | News | Comments

Particulate matter in injections can be harmful when introduced into the bloodstream.

Innovation Pathway

January 12, 2012 6:30 am | by U.S. Food & Drug Administration | News | Comments

The Innovation Pathway aims to shorten the overall time it takes for the development, assessment, and review of breakthrough medical devices.

Consumer Information on: Berlin Heart EXCOR & #xae; Pediatric Ventricular Assist Device (VAD) - H100004

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

The EXCOR® Pediatric VAD is a blood pump that vibrates rhythmically and is designed to assist patients who cannot pump enough blood with their own natural heart. The device can be used in patients who cannot effectively pump blood with their left and/or..

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