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FDA Issues Draft Guidances for Industry on Social Media and Internet Communications About Medical Products

June 18, 2014 2:27 pm | by Thomas Abrams, Director – Office of Prescription Drug Promotion, CDER, FDA | Blogs | Comments

Ongoing changes in technology transform medical products – and the ways that both patients and health care providers learn about those products. In today’s world, in addition to traditional sources of medical product information, patients...

Life-Saving, Smart Regulation on Behalf of Patients with Aortic Stenosis

June 17, 2014 9:50 am | by Jeffrey Shuren, M.D., Director – Center for Devices and Radiological Health, FDA | Blogs | Comments

At FDA’s medical devices center, we have a vision — it’s what we strive for each day in our review and assessment of new medical technology. And patients are at the very core of that vision: “Patients in the U.S. have access to high-quality...

How to Market Your Device

June 16, 2014 9:34 am | by U.S. Food & Drug Administration | News | Comments

Medical devices marketed in the United States are subject to the regulatory controls in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the regulations in Title 21- Code of Federal Regulations (21 CFR) Parts 1-58, 800-1299... 

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CDRH on Track to Improve Device Submission Review Process

June 13, 2014 2:00 pm | by Jeffrey Shuren, M.D., Director – Center for Devices and Radiological Health, FDA | Blogs | Comments

FDA’s Center for Devices and Radiological Health (CDRH) is committed to speeding innovative new medical devices to market and to improving the efficiency of our device submission review process. That’s critical for patients getting access...

Breaking Down the Regulation of LDTs: FDA Jurisdiction

June 13, 2014 1:54 pm | by Richard Park, Contributing Editor | Blogs | Comments

A couple of weeks ago, I reported on a letter that Bradley M. Thompson, JD, and James A. Boiani, JD, attorneys at Epstein Becker Green, recently sent to FDA Commissioner Margaret Hamburg. The attorneys sent this letter on behalf of the... 

Medtronic Heart Valve Approved for Broader Use

June 13, 2014 11:14 am | by The Associated Press | News | Comments

Medtronic Inc. said Thursday that the FDA approved its artificial heart valve, CoreValve, for use in more patients who face serious risks from open-heart surgery, the standard treatment. Medtronic's implant is a less invasive approach to...

FDA Releases First Phase of Global UDI Database

June 13, 2014 9:13 am | by FDA | News | Comments

First phase of the Global Unique Device Identification Database (GUDID): Guidance for Industry is now available. To quickly provide industry with information critical to successful use of the GUDID, we are issuing the GUDID Guidance in two...

Panel Provides Unanimous Favorable Recommendation to FDA for Bard's Drug Coated Balloon

June 12, 2014 8:28 pm | by The Associated Press | News | Comments

C. R. Bard, Inc. today announced that the U.S. Food and Drug Administration’s (FDA) Circulatory System Devices Advisory Panel provided a unanimous favorable recommendation to FDA for use of the Lutonix Drug Coated Balloon PTA Catheter (DCB)...

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Anti-Microbial Coatings with a Long-Term Effect for Surfaces

June 11, 2014 4:08 pm | by INM - Leibniz-Institut für Neue Materialien gGmbH | News | Comments

Researchers at the INM – Leibniz Institute for New Materials have now produced antimicrobial abrasion-resistant coatings with both silver and copper colloids with a long-term effect that kill germs reliably and at the same time prevent germs becoming established. Hygienic conditions and sterile procedures are ...

TIA Encourages HHS Secretary to Examine Changes

June 11, 2014 11:51 am | by Tellecommunications Industry Association | News | Comments

The Telecommunications Industry Association, the association representing the manufacturers and suppliers of high-tech communications networks, joined a number of stakeholders in urging newly-confirmed Secretary of the Department of Health and Human Services Sylvia Burwell to take ...

First Patient Receives HeartAssist5 VAD Following CE Mark Approval

June 9, 2014 5:23 pm | by ReliantHeart | News | Comments

Privately-held ReliantHeart, a leading innovator in mechanical circulatory support therapies, announced the first advanced stage heart failure patient received its next generation HeartAssist5 Ventricular Assist Device (VAD) since the company...

OpenFDA: Innovative Initiative Opens Door to Wealth of FDA’s Publicly Available Data

June 2, 2014 3:48 pm | by Taha A. Kass-Hout, M.D., M.S., Chief Health Informatics Officer and Director – Office of Informatics and Technology Innovation, FDA | Blogs | Comments

Today, I am pleased to announce the launch of openFDA, a new initiative from our Office of Informatics and Technology Innovation (OITI). OpenFDA is specifically designed to make it easier for web developers, researchers, and the public to...

Breaking Down the Regulation of LDTs

June 2, 2014 11:34 am | by Richard Park, Contributing Editor | Blogs | Comments

I received a copy of a letter that Bradley M. Thompson, JD, and James A. Boiani, JD, attorneys at Epstein Becker Green, recently sent to FDA Commissioner Margaret Hamburg. The attorneys sent this letter on behalf of the Combination Products...

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Medtronic Launches Advisa and Ensura SR MRI SureScan Pacemaker Systems in Europe

June 2, 2014 10:22 am | by Medtronic | News | Comments

Medtronic, Inc., today announced CE (Conformité Européenne) Mark and commercial launch of the Advisa and Ensura SR MRI SureScan single chamber pacemaker devices in Europe. Both pacemakers are approved for magnetic resonance imaging (MRI)...

Report on Medical Device Market Outlines Challenges, Opportunities for Cost Containment

May 30, 2014 3:44 pm | by Rich Gedney, CEO, ADMET | Admet, Inc. | Blogs | Comments

The medical device market has experienced tremendous growth, reaching more than $330 billion worldwide. While the industry remains healthy, several challenges face those who design and manufacture medical devices. ADMET serves this market...

2nd Annual Medical Device Global Labeling Strategies Conference

May 30, 2014 9:29 am | Events

The 2nd Annual Medical Device Global Labeling Strategies Conference is a highly informative, content driven forum focusing on the key fundamentals for achieving a compliant global labeling process, including: preparing for UDI compliance...

Unique Device Identification: Three Steps to Compliance

May 29, 2014 9:59 am | by Nick Recht, Enterprise Product Manager, TEKLYNX Americas | Articles | Comments

In the medical device industry, accurate identification has never been more important. Failure to adhere to rules and regulations can be the difference between life and death for patients. Growing concerns about product recalls, counterfeit...

3D Printing a Healthcare Revolution

May 20, 2014 2:22 pm | by Sean Fenske, Editor-in-Chief | Blogs | Comments

3D printing is one of those truly disruptive technologies that comes along very rarely. It is remarkable how many different industry sectors it can touch and impact significantly. Healthcare is just one area where it is making a difference...

PCR Innovation Day Promotes Interaction Between Stakeholders in Cardiovascular Innovation

May 20, 2014 11:41 am | by EuroPCR | News | Comments

The first PCR Innovation Day focused on facilitating a constructive interaction between the key stakeholders—physicians, inventors, entrepreneurs, investors, start-ups, MedTech incubators, regulatory organisations and larger companies —in...

Medtronic Announces CE Mark and Launch of NC Euphora Coronary Balloon

May 20, 2014 10:26 am | by Medtronic | News | Comments

Continuing its commitment to bringing advanced and clinically relevant interventional technologies to market, Medtronic, Inc. has announced CE (Conformité Européene) mark and launch of the NC Euphora Noncompliant Balloon Dilatation Catheter...

May 2014 Digital Edition

May 13, 2014 4:39 pm | by MDT Staff | Digital Editions | Comments

In May, there are three presentations that contribute to the cover focus of in vitro diagnostics. “RFID Enables a Clear Line of Sight to Time Savings” highlights the use of RFID to track compounds, chemicals, and reagents; while “The Role of Polymer...

Building Expertise and Crossing Boundaries to Improve Oversight

May 13, 2014 2:59 pm | by Howard Sklamberg, J.D., Deputy Commissioner for Global Regulatory Operations and Policy, FDA | Blogs | Comments

To keep the food supply safe, have safe, effective, and high quality medical products, and decrease the harms of tobacco product use, we have to work with the rest of the world. As FDA’s Deputy Commissioner for Global Regulatory Operations...

FDA Allows Marketing of Prosthetic Arm that Translates Signals from Person’s Muscles

May 9, 2014 2:11 pm | by FDA | News | Comments

The U.S. Food and Drug Administration (FDA) today allowed marketing of the DEKA Arm System, the first prosthetic arm that can perform multiple, simultaneous powered movements controlled by electrical signals from electromyogram (EMG)...  

Strong Review Performance Brings Innovative Medical Products to Patients

May 8, 2014 3:38 pm | by Margaret A. Hamburg, M.D., Commissioner, FDA | Blogs | Comments

There are many ways FDA supports biomedical innovation as part of our mission to protect and promote public health. We are committed to finding ways to ensure that safe and effective products can get to the people who need them as swiftly...

Recall Report: PT/INR Test Strips Had Significantly Innacurate Results

May 7, 2014 2:13 pm | by Food and Drug Administration (FDA) | News | Comments

Alere is recalling this product due to complaints of patients who had a therapeutic or near therapeutic INR with the Alere INRatio2 PT/INR Professional Test Strip but a significantly higher INR (outside of therapeutic range) when performed...

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