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AdvaMed Statement on House FDASIA Hearing

November 19, 2013 12:07 pm | by AdvaMed | News | Comments

Stephen J. Ubl, president and CEO of the Advanced Medical Technology Association, released the following statement on today’s hearing in the House Energy and Commerce Health Subcommittee on implementation of the FDA Safety and Innovation...

FDA Issues Stern Warning on Medtronic Devices

November 16, 2013 7:19 pm | by David Koenig - AP Business Writer | News | Comments

Federal health officials say that defects in some Medtronic devices used in heart procedures are severe enough that they could cause serious injury or death. The warning covers about 15,000 recalled guidewires, which are inserted through an artery...

New Factors Reshaping Medical Education Programs in the Life Sciences Industries

November 15, 2013 3:50 pm | by PR Newswire | News | Comments

Medical Education groups are often being transformed by regulatory and budget pressures, making it increasingly difficult to effectively educate healthcare practitioners on the safe and effective use of products. With the pressure to reduce budgets...


Consumer Information on: MitraClip Clip Delivery System

November 15, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

  This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications...  

7 Tips for Painless FDA 510(k) Regulatory Submissions

November 13, 2013 3:30 pm | by Vincent Crabtree, Ph.D., Regulatory Advisor and Project Manager, StarFish Medical | Blogs | Comments

FDA Regulatory Clearance using the 510(k) Pre-market Notification process can be a painful experience to unprepared companies. My focus at StarFish Medical is regulatory compliance. I believe it is important to consider Regulatory all the way...

USDM Life Sciences Teams With Inspirage to Help Medical Device Manufacturers Meet FDA's Unique Device Identifier (UDI) Compliance Regulations

November 13, 2013 12:24 pm | by The Associated Press | News | Comments

USDM Life Sciences, a leading global regulatory consulting firm in the life sciences industry, is proud to announce a teaming agreement with Inspirage to provide comprehensive consulting and technology solutions for medical device companies to...

Meeting Notice: December 11, 2013 Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting Announcement

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

On December 11, 2013, the committee will discuss, make recommendations, and vote on information related to the premarket approval application regarding the Boston Scientific WATCHMAN Left Atrial Appendage (LAA) Closure Technology. The WATCHMAN...

Health Website's Security Prompts Worries

November 6, 2013 4:05 pm | by Ricardo Alonso-Zaldivar, Associated Press | News | Comments

Obama administration officials are facing mounting questions about whether they cut corners on security testing while rushing to meet a self-imposed deadline to launch online health insurance markets. Documents show that the part of that consumers interact with ...


Photos of the Day: Venezuela's Crippled Healthcare

November 6, 2013 12:07 pm | by The Associated Press | News | Comments

Venezuela's 1999 constitution guarantees free universal health care to Venezuelans, who sit on the world's largest proven oil reserves. President Nicolas Maduro's government insists it's complying. Yet of the country's 100 fully functioning public hospitals ...

Doctors Say Venezuela's Health Care in Collapse

November 6, 2013 11:59 am | by Frank Bajak, Associated Press | News | Comments

Evelina Gonzalez was supposed to undergo cancer surgery in July following chemotherapy but wound up shuttling from hospital to hospital in search of an available operating table. On the crest of her left breast, a ...     

Samsung Aims to Be Top Medical Device Maker

November 6, 2013 10:38 am | by Youkyung Lee, AP Technology Writer | News | Comments

Samsung wants to be the top medical device maker through acquiring companies and developing its own technologies. In the last three years, Samsung spent $1 billion to buy 14 companies in medical equipment, mobile software and services ...

Testosterone Treatments Linked to Heart Risks

November 6, 2013 10:18 am | by Lindsey Tanner, AP Medical Writer | News | Comments

Testosterone treatments may increase risks for heart attacks, strokes and death in older men with low hormone levels and other health problems, a big Veterans Affairs study suggests. The results raise concerns about ...     

RFID Chips for Breast Implants

November 1, 2013 10:45 am | by Business Wire | News | Comments

VeriTeQ Corporation, a provider of implantable medical device identification and radiation dose measurement technologies, has announced that it has delivered its first order of 2,000 Q Inside Safety Technology radio frequency identification...


U.S. FDA shares more details on MDSAP international audit pilot

October 28, 2013 3:47 pm | by Mass Device | News | Comments

Following the Australian Therapeutic Goods Administration’s recent news that Australia, Brazil, Canada and the US will launch a pilot for the Medical Device Single Audit Program (MDSAP) for medical devices in January 2014, The US Food and Drug... 

Boston Scientific Receives CE Mark for Lotus Valve System

October 28, 2013 2:09 pm | by PR Newswire | News | Comments

Boston Scientific Corporation has received CE Mark for the Lotus™ Valve System, the company's advanced transcatheter aortic valve replacement (TAVR) technology.  This key approval offers a unique and effective new treatment alternative for...

Animal-Derived Component Free Molding for Medical Devices

October 25, 2013 3:38 pm | by David Johnson, Engineering Manager; Steve Fischer, Senior Manufacturing Engineer; Ryan Fuhr, Senior Manufacturing Engineer; Sven Nelson, Project Manager; and John Haley, VP of Operations | Advanced Molding Technology | Blogs | Comments

A group of representatives from Advanced Molding Technologies was a part of the staff written article, “Molders Address Biggest Device Issues.” They took time to present an array of responses that were not all able to be included in the article...

Lasers Offer an Automated Way to Test Drinking Water

October 22, 2013 10:17 am | by Fraunhofer-Gesellschaft | News | Comments

To keep drinking water clean, experts are constantly monitoring our supply to check it for contaminants. Now laser technology will give them a helping hand: a new system automatically analyzes water samples at the waterworks itself. In today’s world, we simply cannot ...

Shutdown ends, FDA user fees begin

October 17, 2013 4:10 pm | by Mass Device | News | Comments

The FDA can begin collecting user fees from medical device companies for fiscal 2014 now that the federal shutdown is over. The watchdog agency announced new rates for the fees in August, but couldn't begin collecting them when the fiscal year...

2014 User Fees

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

Information regarding MDUFA III fees. Small businesses with an approved SBD with gross receipts or sales of $30 million or less are eligible to have the fee waived on their first PMA, PDP, PMR or BLA.                                

How Will Proposed ISO 10993-1 Change Impact Your Biocompatibility Plans?

October 15, 2013 3:42 pm | by Mark Drlik, Mechanical Engineer and Project Manager, StarFish Medical | Blogs | Comments

Document UCM348890 (FDA’s April 2013 proposal to change the guidance document for ISO 10993-1) seems pretty straight forward—with things like testing details associated with genotoxicity and how to go about labeling your device as “BPA-free”...

FDA Advisory Panel Recommends Expanded Indication for Medtronic's CRT Devices

October 8, 2013 6:06 pm | by The Associated Press | News | Comments

The U.S. Food and Drug Administration's (FDA) Circulatory Systems Devices Advisory Panel today voted that biventricular (BiV) pacing with Medtronic, Inc. (NYSE: MDT) devices is beneficial for treating patients who have atrioventricular (AV) block...

The FDA’s UDI Rule is Final! What Now?

October 8, 2013 12:02 pm | by Ken Koldan, Business Development Manager, FLEXcon | Blogs | Comments

The FDA published the final rule for the unique device identification system (UDI) during the UDI Conference in Baltimore, MD and released it on September 24, 2013. This much anticipated rule will provide a consistent way to identify medical devices and ensure that proper safety regulations are being followed.

BREAKING: House votes to fund FDA past shutdown

October 7, 2013 7:18 pm | by Mass Device | News | Comments

The U.S. House of Representatives voted tonight to fund the FDA until the federal shutdown ends or until Dec. 15, whichever comes first. The lower chamber approved on a 235-162 vote a joint resolution by Rep. Robert Aderholt (R-Ala.) that restores funding to the level established by sequestration, which is about $200 million less than originally authorized.

Don’t Need a Cleaning and Disinfection Validation? Check Again!

October 7, 2013 3:59 pm | by Mike Neilson, Section Leader, Healthcare Reprocessing, BS, RM (NRCM) CQPA (ASQ) | Nelson Laboratories, Inc. | Blogs | Comments

When you hear the term “reusable medical devices,” you may think of surgical instruments like forceps or scissors. Reusable devices often have intimate patient contact, become grossly soiled during use, and need to be reprocessed before their next use.

FDA Shutdown Could Cause Major Delays to Heart Failure Device Approvals

October 7, 2013 10:33 am | by GlobalData | News | Comments

The recent government shutdown will significantly impact upon FDA services and operations, especially in the heart failure (HF) and arrhythmia markets, due to the agency’s limited proactive abilities for device approvals, according to an analyst with research and consulting firm GlobalData.

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