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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”...

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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 | 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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Evaluating FDA Guidance for RF Wireless Technology in Medical Devices

October 7, 2013 8:55 am | by Kenneth MacCallum, PEng, Principal Engineering Physicist, Starfish Medical | Blogs | Comments

Last month, the FDA issued a guidance document for RF wireless technology in medical devices. Not surprisingly, the FDA is recommending a risk-based approach to design, testing, deployment, and maintenance of medical device development. This follows the risk-based approach to safety that was introduced in the 3rd edition of 60601-1.

GE Healthcare lands EU approval for Vivid E9 ultrasound

October 4, 2013 11:29 am | by Mass Device | News | Comments

Medical technology giant GE Healthcare won European regulatory approval for the latest in its line of Vivid E9 ultrasound systems with XDclear technology. The next-generation system with XDclear features enhanced image quality in 2D, 4D, color and Doppler, tools that can help with hard-to-image patients, including those who are obese.

Delivering Clarity on FDA’s Updates to mHealth and Wireless Guidelines

October 4, 2013 9:58 am | by The Technology Partnership | News | Comments

Last week the FDA's mHealth guidance was published in its final form, after being in draft status since 2011. This marks significant progress in developing opportunities for mHealth and connected medical services and follows publication of supporting technical recommendations on wireless and mHealth technologies for use in medical devices in August and September this year.

FDA meeting sacrificed to government shutdown

October 3, 2013 9:29 am | by Mass Device | News | Comments

Medical device makers will have to wait a little longer for progress on implementation of the FDA's Safety & Innovation Act, now that a meeting with a Senate Health, Education, Labor & Pensions committee has been canceled amid the federal government shutdown.

What's changing, what's not, in a shutdown

October 1, 2013 3:38 am | by Calvin Woodward - Associated Press | News | Comments

Campers in national parks are to pull up stakes and leave, some veterans waiting to have disability benefits approved will have to cool their heels even longer, many routine food inspections will be suspended and panda-cams will go dark at the shuttered National Zoo.

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CareFusion Provides Update On Voluntary Recall Of AVEA® Ventilator

September 30, 2013 4:16 pm | by PR Newswire | News | Comments

The company initiated the voluntary recall on Sept. 3, 2013. The FDA has classified this action as a Class I recall. A Class I recall is defined as a reasonable probability of serious adverse health consequences or death associated with use of the defective units.

FDA Rule Mandating Unique Device Identification for Reusable Medical Devices Creates New Market Opportunity for VeriTeQ in Breast Implant Sizers and Other Reprocessed Devices

September 30, 2013 8:30 am | by Business Wire | News | Comments

Digital Angel Corporation, a provider of implantable medical device identification and radiation dose measurement technologies, following its recent share exchange with VeriTeQ Acquisition Corporation, discussed today a new market opportunity for identifying breast implant sizers, which was created, in part, by the FDA Final Rule for Unique Device Identification, announced on September 20, 2013.

QPharma’s Medical Device Division Offers Guidance on UDI Final Rule

September 26, 2013 2:13 pm | by Business Wire | News | Comments

On Friday, September 20, the final Unique Device Identification (UDI) rule was issued by the Food and Drug Administration in conjunction with the 2013 UDI Conference in Baltimore, Maryland. Tom Beatty, Sr. Principal, UDI Compliance at QDevice, the medical device consulting division of QPharma, was in attendance for the announcement.

FDA Broadens Options for Using Edwards Heart Valve

September 24, 2013 11:45 am | by The Associated Press | News | Comments

The Food and Drug Administration said Monday that it has approved broader use of an innovative artificial heart valve that can be implanted without major surgery, allowing surgeons to insert the implant through multiple pathways. The agency approved revised labeling for Edwards Lifesciences' Sapien heart valve...

FDA Lays Out Rules for Some Smartphone Health Apps

September 24, 2013 11:38 am | by The Associated Press | News | Comments

Food and Drug Administration officials say they will begin regulating a new wave of applications and gadgets that work with smartphones to take medical readings and help users monitor their health. With the rise of the iPhone, Android and other mobile devices has come a flood of applications designed to help people stay healthy.

GS1 Standards Assist Manufacturers in Meeting New FDA Requirements for Unique Device Identification

September 24, 2013 9:03 am | by The Associated Press | News | Comments

GS1 Standards can help manufacturers comply with a new regulation released by the FDA that establishes a national unique device identification system for medical devices to increase patient safety. A new GS1 UDI resource Web page is now available to offer GS1 Standards implementation guidance.

Theorem Clinical Research Puts Medical Device Expertise on Display at Outsourcing in Clinical Trials New England

September 24, 2013 8:00 am | by Business Wire | News | Comments

Theorem Clinical Research, one of the leading CROs in the medical device arena, will be in Boston for the Outsourcing in Clinical Trials New England conference, Oct. 1-2 at the Westin Boston Waterfront in Boston. “A whole section of the agenda is devoted to medical devices and the industry-specific challenges sponsors face in gaining regulatory approval...

FDA expands clearance for Intuitive Surgical's FireFly imaging system

September 23, 2013 2:27 pm | by Mass Device | News | Comments

Intuitive Surgical said the FDA expanded the 510(k) clearance for its FireFly fluorescence imaging system to use during gallbladder surgery using its da Vinci robotic surgery device. The device uses a video camera and fluorescent dye to show blood flow in vessels and tissue, by causing blood to appear green and bloodless tissue as gray, according to a press release.

FDA Releases Final Rule for Unique Device Identification

September 23, 2013 8:30 am | by Business Wire | News | Comments

Digital Angel Corporation, a provider of implantable medical device identification and radiation dose measurement technologies, following its recent share exchange with VeriTeQ Acquisition Corporation (“VeriTeQ”), announced today that the U.S. Food and Drug Administration (“FDA”) has released its Final Rule for Unique Device Identification (“UDI”).

FDA Requires Tracking Codes on Medical Implants

September 20, 2013 10:37 am | by The Associated Press | News | Comments

The Food and Drug Administration published new rules Friday that require most medical devices sold in the U.S. to carry a unique code, identifying its make, manufacture date and lot number. The codes will be stored in a publicly accessible database to help regulators, doctors and companies monitor safety issues with devices.

Sapheon Submits First Module of PMA Application for VenaSeal Sapheon Closure System

September 20, 2013 12:01 am | by The Associated Press | News | Comments

Sapheon Inc. announced today that it submitted the first module of the pre-market approval (PMA) application for the VenaSeal® Sapheon Closure System to the U.S. Food and Drug Administration (FDA). The submission places Sapheon on track for timely FDA review and expected product launch in the first half of 2015.

Keystone Heart’s TriGuard Cerebral Protection Device Receives CE Marking

September 19, 2013 10:50 am | by PR Newswire | News | Comments

The CE marked TriGuard is the only device designed to cover all three aortic cerebral branches to minimize the risk of cerebral damage during Transcatheter Aortic Valve Replacement (TAVR) and other cardiovascular procedures. It is the only system designed for placement via one of two femoral artery access ports.

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