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Class I Medical Device Recall: Symbios GOPump and GOBlock Kits

June 12, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

The affected products may have excessively high flow rates. As a result, medications could be delivered too quickly from the balloon to the surgical site and cause patient toxicity due to the rapid influx of medication. This can lead to serious illness...

Teleflex Receives FDA Clearance for ARROW NextStep Retrograde Femoral Length Dialysis Catheters

June 10, 2013 5:00 pm | by Business Wire | News | Comments

Teleflex Incorporated (NYSE:TFX), a leading global provider of medical devices for critical care and surgery, has announced it has received FDA 510(k) clearance to market its ARROW® NextStep® Retrograde Femoral Length Dialysis Catheters. Designed for clinician ease of insertion and sustained high flow rates, the ARROW NextStep Retrograde Femoral Length Catheters further strengthen the NextStep Hemodialysis Catheter portfolio.

Evaluation of Automatic Class III Designation (De Novo) Decision: K121291 added

June 3, 2013 12:00 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. The De Novo process applies to low and moderate risk devices that have been classified as class III because they were found not substantially equivalent (NSE) to existing devices.

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Consumer Updates - WANTED: Consumers to Report Problems

June 3, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

A new consumer-friendly form is now available for making reports to MedWatch, the Food and Drug Administration's (FDA) on-line system for collecting information about serious problems with drugs, medical devices and other FDA-regulated products.

Commentary: Obamacare’s Other Surprise

May 25, 2013 7:13 am | by Thomas L. Friedman, Associated Press | News | Comments

We’ll just have to wait and see whether the Affordable Care Act, as the health care law is officially known, surprises us on the downside. But there is one area where the law already appears to be surprising on the upside. And that is the number of health care information startups it’s spurring.

PMA Final Decisions for March 2013

May 24, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

Below are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions. This list is generated on a monthly basis. A PDF document that contains the "Approval letter and Summary of Safety and Effectiveness" is being added to this listing for each PMA. The PMA number will appear as a link if this document is available.

Class I Medical Device Recall: Cook Medical, Inc., Zilver PTX Drug-Eluting Peripheral Stent

May 24, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

Reason for Recall: Cook Medical received a small number of complaints that the delivery system of the device had separated at the tip of the inner catheter. Potential adverse events that may occur in cases where the inner deliver catheter breakage...

Improving Patient Safety with Unique Device Identification

May 23, 2013 11:35 am | by Warren Ward-Stacey, Sales Director, PRISYM ID | Blogs | Comments

Medical device manufacturers should welcome the proposed ruling for Unique Device Identification (UDI); however, being compliant by the effective date (based on classification) for some organizations may be a concern. UDI aims to identify errors involving medical devices and provide more rapid resolution of device problems.

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Meeting Announcement: June 26, 2013 General and Plastic Surgery Devices Panel of the Medical Devices Meeting Announcement

May 23, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

On June 26, 2013, the committee will discuss and make recommendations regarding the possible reclassification of blood lancet devices.  The committee will discuss whether new scientific data are sufficient to support the reasonable assurance of safety and effectiveness to develop special controls that support regulation of blood lancets from class I to class II and class III. 

ACRO Joins Coalition of Small Business Innovators

May 21, 2013 11:09 am | by The Associated Press | News | Comments

WASHINGTON--(BUSINESS WIRE)--May 21, 2013--The Association of Clinical Research Organizations announced today it has joined the Coalition of Small Business Innovators (CSBI). CSBI is a national, non-partisan coalition of organizations dedicated to stimulating sustained, private investment in...

BIO Joins Coalition of Small Business Innovators

May 21, 2013 10:30 am | by The Associated Press | News | Comments

WASHINGTON--(BUSINESS WIRE)--May 21, 2013--The Biotechnology Industry Organization (BIO) announced today it has joined the Coalition of Small Business Innovators (CSBI). CSBI is a national, non-partisan coalition of organizations dedicated to stimulating sustained, private investment in small,...

Coalition of Small Business Innovators Launches to Encourage a Tax Code that Creates Jobs and Promotes Long-Term Economic Growth

May 21, 2013 10:00 am | by The Associated Press | News | Comments

WASHINGTON--(BUSINESS WIRE)--May 21, 2013--The Coalition of Small Business Innovators (CSBI) launches today with 15 organizations representing thousands of pre-revenue small businesses that employ millions of Americans in all 50 states. The Coalition aims to promote small business advancement as...

Letter to Biosense Technologies Private Limited concerning the uChek Urine Analyzer

May 21, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

It has come to our attention that you are currently marketing the uChek Urine analyzer, which is intended for use with Siemens Multistix SG10, Siemens Multistix SG, Siemens Uristix, Bayer Diastix, and Bayer Keto-Diastix reagent strips for the qualitative and semi-quantitative determination of urine analytes including glucose, urobilinogen, pH, ketone, blood, protein, bilirubin, nitrite, leukocyte, and specific gravity. 

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Preparing for Medical Electronics RoHS Compliance

May 20, 2013 2:33 pm | by George Karalias, Director of Marketing & Communications, Rochester Electronics | Blogs | Comments

Next July, certain medical electronics will fall under the scope of RoHS—the European Union’s Restriction on Hazardous Substances. In terms of the electronics industry, that is now a tight deadline for manufacturers. Medical devices that have so far been exempt from RoHS fall into scope under the RoHS Recast (RoHS 2) beginning in July 2014.

Center for Devices and Radiological Health Appeals Processes - Guidance for Industry and Food and Drug Administration Staff

May 16, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

This guidance document describes the processes available to outside stakeholders to request additional review of decisions or actions by CDRH employees. This guidance supersedes “Medical Device Appeals and Complaints: Guidance for Dispute Resolution,” and “Resolving Scientific Disputes Concerning The Regulation of Medical Devices, A Guide to Use of the Medical Devices Dispute Resolution Panel; Final Guidance for Industry and FDA."

Center for Devices and Radiological Health Appeals Processes: Questions and Answers About 517A - Draft Guidance for Industry and Food and Drug Administration Staff

May 16, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

This draft guidance document provides CDRH proposed interpretation of key provisions of Section 517A of the Food, Drug and Cosmetic Act (FD&C Act), which was added by section 603 of the FDA Safety and Innovation Act (FDASIA) of 2012, as those provisions..

Why Medtech Startups Are Moving to Ireland

May 13, 2013 2:33 pm | by Eddie Goodwin, Manager, Boston Office, Enterprise Ireland | Blogs | Comments

It’s no secret that getting a medical device to market can be a lengthy, frustrating process. Facing the new medical device excise tax and lack of clarity from the FDA around regulatory policies, medtech startups are now starting to rethink launching in the U.S.

PatientsLikeMe and CISCRP Team up with Sanofi to Spotlight Medical Heroes and Clinical Trial Participation

May 13, 2013 10:00 am | by The Associated Press | News | Comments

CAMBRIDGE, Mass.--(BUSINESS WIRE)--May 13, 2013--PatientsLikeMe and the nonprofit Center for Information and Study on Clinical Research Participation (CISCRP) announce a new partnership with global healthcare leader Sanofi (NYSE: SNY) to raise awareness about the benefits of participating in...

Meeting Announcement: July 18, 2013 Dental Products Panel of the Medical Devices Advisory Committee

May 13, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

On July 18, 2013, the committee will discuss and make recommendations on the proposed regulatory classification for dental devices known as Endosseous Dental Implants (Blade-form), one of the remaining preamendments Class III devices. The Class III blade-form endosseous dental implant is a device placed into the maxilla or mandible and composed of biocompatible material with sufficient strength to support a dental restoration.

Medical Device Global Labeling Strategies Conference

May 9, 2013 2:07 pm | by MDT Staff | Events

Gain best practices in overcoming international labeling challenges at the Medical Device Global Labeling Strategies Conference, July 24-25, 2013 in Minneapolis, MN. This premier marcus evans event will bring together leading medical device labeling professionals to discuss how to successfully create a label on both a national and international scale.

Meeting Announcement: June 13, 2013 Microbiology Devices Panel of the Medical Devices Advisory Committee

May 8, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

The committee's discussion will involve making recommendations regarding regulatory classification to either confirm class I or reclassify these devices into class II with special controls. The committee will address issues such as device performance and public health impact to determine whether special controls are needed to ensure the safety and effectiveness of these tests through their total product life cycle.

Much Ado About Nothing: The Impact of the Medical Device Excise Tax

May 7, 2013 3:19 pm | by Michael Lewis, Writer, Money Crashers Personal Finance | Blogs | Comments

Critics of the new 2.3% medical device excise tax are hitting new heights with their claims of dire consequences. Conservative blogger and attorney Johnathan Emord blogged that the tax will "wipe out an entire industry," and further asserts that the tax is "one of the most draconian tax burdens in history." What are the facts? Is the industry overreacting?

Meeting Announcement: June 27, 2013 Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee

May 3, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

On June 27, 2013, during session I, the committee will discuss and make recommendations regarding the proposed classification of sorbent hemoperfusion systems, one of the remaining preamendments class III devices. The class III sorbent hemoperfusion system is a device intended for the treatment of poisoning, drug overdose, hepatic coma, and metabolic disturbances.

Obesity Treatment Devices

May 3, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

Obesity is a major public health concern in the United States and has been linked to many health problems such as heart disease, stroke, diabetes, high blood pressure, sleep disorders, and breathing problems. Obesity (an excessive amount of body fat)...

AACR Opposes Bill to Exempt Cigars From FDA Regulation

May 1, 2013 9:00 am | by AACR | News | Comments

The American Association for Cancer Research (AACR) formally issued letters to all members of the House of Representatives and the Senate urging them to oppose recently introduced legislation that would exempt many cigars from regulation. The FDA currently regulates cigarettes, smokeless tobacco and roll-your-own cigarette tobacco, and...

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