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Structure of Regulatory Affairs in Medical Device Companies Impacting Organizational Efficiency

January 31, 2014 6:30 pm | by PR Newswire | News | Comments

Ensuring that companies comply with the plethora of global regulations pertaining to developing and marketing new medical device products is a challenge faced by many organizations. To cope with these challenges, Regulatory Affairs groups...

New Developments in 2014 Bring Challenges for Designers

January 31, 2014 1:53 pm | by Mike Brousseasu, Manager — Safety Group, and Joe Langton, Business Service Line Leader — Chemical, Intertek | Blogs | Comments

In the coming year, medical device manufacturers will need to focus on getting their products compliant, available, and possibly re-designed to keep up with the ever-changing standards associated with the medical device industry. The Affordable...

Covidien Receives Japanese Regulatory Approval for Reinforced Stapling Reload Technology

January 27, 2014 5:11 pm | by The Associated Press | News | Comments

Covidien plc has announced that its Japanese subsidiary, Covidien Japan Inc., has received Shonin approval from the Japanese Ministry of Health, Labor and Welfare for its Endo GIA Reinforced Reload with Tri-Staple technology. This approval...

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Transforming the Medical Devices Industry Through Unique Device Identification

January 27, 2014 12:36 pm | by Rajeev Kapoor & Chris Paddison, A.T. Kearney | Articles | Comments

As consumers, of course, we’re all familiar with bar codes. But consider the profound transformations resulting from this universal product identifier. Today’s consumer-goods industries rely on bar code–powered innovations in inventory... 

Covidien Receives FDA Clearance for LigaSure Maryland Jaw

January 23, 2014 11:17 am | by Business Wire | News | Comments

Expanding its industry-leading vessel and tissue sealing portfolio, Covidien received U.S. Food and Drug Administration (FDA) 510(k) clearance for the LigaSure Maryland jaw open/laparoscopic sealer/divider. In addition, Covidien completed...

Many CV Devices Approved by Process that Often Does Not Require New Clinical Data

January 23, 2014 10:40 am | by The JAMA Network Journals | News | Comments

Many cardiac implantable electronic device models currently in use were approved via a Food and Drug Administration review process in which the models were assumed safe and effective based on approval of prior versions of the device, according...

Solution Helps Manufacturers Achieve Value as They Invest in Meeting UDI Requirements

January 22, 2014 11:53 am | by Business Wire | News | Comments

The first deadline for manufacturers to comply with the U.S. Food and Drug Administration’s (FDA) Unique Device Identification (UDI) rule is just over eight months away. Today, GHX announces it will offer an industry solution that enables...

MedTech Strategic Convergence Set for 2014

January 17, 2014 12:28 pm | by Deb Kacera, Regulatory & Industry Strategist, Pilgrim Software Inc. | Pilgrim Quality Solutions | Blogs | Comments

In 2014, we will see the next evolution of the most effective utilization of resources across the medical device industry, based on “smart” information that will touch almost every healthcare stakeholder, where key data will have a tighter...

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CEA Joins Industry Groups in Sponsoring Educational Series on Health App Development Under FDA Regulation

January 17, 2014 11:53 am | by Consumer Electronics Association | News | Comments

Today, the Consumer Electronics Association announced its sponsorship of an educational program series called the “Mobile Medical Apps (MMA) Roadshow: Managing App Development under FDA Regulation,” joining a consortium of six leading... 

Direct Part Marking for UDI Needs

January 16, 2014 3:01 pm | by Gerry Gunderson, CPP, VP of Engineering, Quality Tech Services | Blogs | Comments

The Final Rule for FDA’s Unique Device Identification (UDI) mandate is now released and will be in focus in 2014. Class III device manufacturers will need to comply by September 2014, unless granted an exception (and excluding grandfathered...

Google gets in hot water over targeted healthcare ads

January 16, 2014 7:29 am | by Mass Device | News | Comments

Internet and technology giant Google agreed to overhaul its healthcare-related advertising practices after Canadian regulators accused the company of violating privacy laws by using search histories to target users with healthcare-related...

FDA dings Philips on InnerCool RTx component recall

January 15, 2014 5:09 pm | by Mass Device | News | Comments

The FDA dinged Philips for tardiness in its notification of the recall of a component for its InnerCool RTx body temperature control device in a warning letter sent last month. Philips issued a recall in January 2012 of the main control board for the...

AdvaMed Applauds Restoration of FDA User Fees in Appropriations Bill

January 15, 2014 12:22 pm | by AdvaMed | News | Comments

Stephen J. Ubl, president and CEO of the Advanced Medical Technology Association (AdvaMed), issued the following statement today following the release of the federal government’s fiscal year 2014 omnibus appropriations legislation. “AdvaMed...

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Evaluation of Automatic Class III Designation (De Novo) Summaries

January 15, 2014 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 novel devices of low to moderate risk that had automatically been placed in Class III after receiving...

USP <1115>—Bioburden Control of Nonsterile Drug Substances and Products

January 14, 2014 1:40 pm | by Jonathan Swenson, Microbiology Department Manager, B.S., RM (NRCM), Nelson Labs | Nelson Laboratories, Inc. | Blogs | Comments

The control of microorganisms when manufacturing products that are nonsterile is an ongoing challenge. Since the products are intended to be “nonsterile,” there is an inherent acceptance that organisms may be present in the product; however...

FDA mandates pediatric data requirements for new medtech applications

January 13, 2014 6:38 pm | by Mass Device | News | Comments

The FDA this month finalized a rule requiring more pediatric patient information from medical devices going through the premarket approval pathway, even if the products are intended for adults. The requirement, part of the Food & Drug...

3 Major Trends in Barcode Labeling for Medical Devices

January 13, 2014 2:23 pm | by Nick Recht, Enterprise Product Manager, TEKLYNX Americas | Articles | Comments

Three major trends are flowing through the medical device industry, promoting patient safety and implementing positive changes. How will these trends affect your labeling processes? They will change the way you label product, help minimize...

Absorbable Vascular Stents Are Subject of New Surgical Devices Standard

January 13, 2014 11:50 am | by ASTM International | News | Comments

Patients with blockages in their coronary vasculature have historically been treated with permanent metallic stents, metal mesh tubes that open clogged blood vessels, restore blood flow and keep the vessel open over time. Certain patients...

MolecularHealth Registers for Medical Device Accreditation in Germany

January 13, 2014 9:00 am | by The Associated Press | News | Comments

MolecularHealth GmbH, the European arm of MolecularHealth, announced today that it formally started the registration of its proprietary oncology treatment decision support software as a medical device with DIMDI, the German Institute of Medical...

Is Google working on a medical device?

January 10, 2014 2:46 pm | by Mass Device | News | Comments

FDA medtech officials met last month with members of Google's clandestine "X" research team, raising speculations about a foray into medical devices for the group that was behind Google Glass and the company's self-driving car. A quartet of...

Setting the Bar for Blood Glucose Meter Performance

January 10, 2014 2:34 pm | by Courtney Lias, Director, Division of Chemistry and Toxicology Devices, CDRH | Blogs | Comments

Many of the nearly 19 million Americans diagnosed with diabetes must monitor their blood glucose (sugar) frequently throughout the day using an at-home meter to make sure that their blood glucose is within a safe range. The ability to measure...

CareFusion to Pay $40.1M in False Claims Case

January 10, 2014 10:43 am | by The Associated Press | News | Comments

CareFusion Corp. has agreed to pay $40.1 million to settle allegations it paid kickbacks and promoted its medical technology products for uses not approved by the Food and Drug Administration. The Justice Department announced the settlement...

Class I Medical Device Recall: Covidien, Puritan Bennett 840 Series Ventilator - Software Problem

January 9, 2014 12:00 am | by U.S. Food & Drug Administration | News | Comments

Due to a software problem, a diagnostic code (XB0069) may be triggered. This causes the ventilator to stop functioning, triggering the safety alarm and causing the patient to suddenly be required to breathe on his or her own. These devices...

Evaluation of Automatic Class III Designation (De Novo) Summaries (K123250 letter added)

January 9, 2014 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 novel devices of low to moderate risk that had automatically been placed in Class III after receiving...

SkinRex issued FDA warning letter

January 8, 2014 12:36 pm | by Mass Device | News | Comments

Korean cosmetic medical device company SkinRex Co. is in hot water with the FDA after the federal watchdog agency issued a warning letter over the marketing of its Cavi-Lipo device. Seoul-based Skinrex is focused on skincare and weight issues...

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