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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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VeriTeQ Endorses England’s Decision to Launch Breast Implant Registry to Track Procedures and Devices

January 8, 2014 8:30 am | by The Associated Press | News | Comments

VeriTeQ Corporation, a provider of implantable medical device identification and radiation dose measurement technologies, announced today that a new breast implant registry will be launched in England beginning early this year to track breast...

FDA Reclassifies ECP Devices for Refractory Angina as Class II

January 6, 2014 4:25 pm | by PR Newswire | News | Comments

Vasomedical, Inc., a diversified medical technology company specializing in the design, manufacture and sale of medical devices including EECP® (Enhanced External Counterpulsation) Therapy systems, the gold standard of ECP therapy, announced...

Driving Innovation Is a Key Part of Our Mission

January 6, 2014 2:43 pm | by Margaret A. Hamburg, M.D., Commissioner, FDA | Blogs | Comments

Ensuring the safety of the food supply and the safety and effectiveness of drugs, devices and biologics has always been at the core of FDA’s responsibility to protect the public health – and always will be. But what is often lost or neglected...

Class I Medical Device Recall: GE Healthcare, LLC - Multi Absorber Original, Disposable - Model M1173310

January 6, 2014 12:00 am | by U.S. Food & Drug Administration | News | Comments

The Multi Asborber, Original may have a thin wall condition, which may lead to small holes in the water (drain) tube. This may result in loss of anesthetic gases, ventilations and oxygenation. This product may cause serious adverse health...

Get to Know IEC60601-1 3rd Edition Before Selecting Your Medical Power Supply

January 3, 2014 1:15 pm | by Jay vanWormer, Murata Power Solutions | Murata Power Solutions | Articles | Comments

Standards and their implementation can often cause a lot of confusion, and the 3rd edition of the medical safety standard IEC60601-1 is no exception. Initially ratified as early as 2005, it has only been since the recent withdrawal of the...

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FDA shifts regulatory requirements for intra-aortic balloons

January 3, 2014 12:52 pm | by Mass Device | News | Comments

The FDA issued a final rule reclassifying certain intra-aortic balloons and demanding more from others, according to a notice in the Federal Register. The new rule eases regulation on intra-aortic balloons and pumps indicated for acute... 

510(k) Submission Process

January 3, 2014 12:00 am | by U.S. Food & Drug Administration | News | Comments

Premarket Notification (510(k)) submissions for medical devices are reviewed by FDA’s Center for Devices and Radiological Health (CDRH), specifically, the Office of Device Evaluation (ODE) and the Office of In Vitro Diagnostics and Radiological...

Robotic surgery complaints become FDA complaints

January 2, 2014 5:05 pm | by Mass Device | News | Comments

As patient complaints mount in lawsuits against Intuitive Surgical and its da Vinci robot-assisted surgical platform, physicians and researchers are shifting some of the blame to the FDA's postmarket surveillance systems as an inadequate...

UNOS to Oversee Hand, Face Transplants Like Organs

December 27, 2013 9:42 am | by Lauran Neergaard, AP Medical Writer | News | Comments

Sure your liver or kidney could save someone's life. But would you donate your hands, or your face? Signing up to become an organ donor may get more complicated than just checking a box on your driver's license. The government is preparing...

Study: Hip implant regulatory review 'entirely inadequate'

December 24, 2013 9:59 am | by Mass Device | News | Comments

A group of U.K. researchers is calling for a major shift in regulation of orthopedic hip implants, warning that a significant number of the devices get on the market without providing much evidence of their safety or efficacy. University...

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CDRHLearn: Intro to UDI and GUDID Overview

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

Listed below are the courses CDRH currently offers (Overview of Regulatory Requirements: Medical Devices; Guidance Documents and Standard Operating Procedures (SOPs); etc.) Additional online courses are being developed and will be posted...

Survey: Regulatory Agencies Viewed as Unprepared for Nanotechnology

December 19, 2013 11:06 am | by University of California - Santa Barbara | News | Comments

Three stakeholder groups agree that regulators are not adequately prepared to manage the risks posed by nanotechnology, according to a paper published in the peer-reviewed journal PLOS One. In a survey of nano-scientists and engineers...  

USDM Life Sciences Hires FDA's Unique Device Identification Architect, Jay Crowley as Vice President of UDI Practice

December 19, 2013 10:39 am | by The Associated Press | News | Comments

USDM Life Sciences, a leading global regulatory consulting firm in the life sciences industry, hires Jay Crowley as Vice President of the Unique Device Identification (UDI) practice. As Senior Advisor for Patient Safety in the Food and Drug...

FDA: Intuitive Surgical recalls are Class II

December 18, 2013 4:38 pm | by Mass Device | News | Comments

A pair of recalls affecting more than 110,000 components of Intuitive Surgical's flagship da Vinci surgical robot pose only a slight risk of serious consequences, the FDA said this week. Intuitive notified customers Nov. 15 of the potential...

GS1 Named an Accredited Issuing Agency for UDI by FDA

December 17, 2013 12:40 pm | by GS1 | News | Comments

GS1, a leading global standards organization, was accredited today by the U.S. Food and Drug Administration (FDA) as an issuing agency for unique device identifiers (UDIs). Global GS1 Standards, administered in the U.S. by GS1 US, were recognized...

CE Mark and First Implants of Boston Scientific’s X4 Quadripolar CRT-D Systems

December 17, 2013 10:02 am | by PR Newswire | News | Comments

Boston Scientific Corporation has received CE Mark approval of its X4 line of quadripolar CRT-D systems, including the AUTOGEN X4, DYNAGEN X4, and INOGEN X4 cardiac resynchronization therapy defibrillators (CRT-Ds), a suite of ACUITY X4... 

FDA OKs eNeura's novel migraine pain treatment stim

December 17, 2013 9:29 am | by Mass Device | News | Comments

Medtech maker eNeura Therapeutics won FDA clearance to market its 1st-of-its-kind Cerena transcranial magnetic stimulator, landing regulatory approval through the agency's less-stringent de novo premarket review pathway. The Cerena TMS is...

Medical Device Reclassification

December 17, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

As experience and knowledge about a device increase, the original classification of a device can be changed through reclassification. Two reclassification processes for medical devices described in the Food Drug and Cosmetic Act are explained...

Overview of Medical Device Classification and Reclassification

December 17, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

On July 9, 2012, Congress enacted the Food and Drug Administration Safety and Innovation Act (FDASIA). Section 608(c) of FDASIA requires the FDA to annually post the number and type of medical devices reclassified in the previous calendar...

Designing Medical Devices to Meet FDA Security Guidelines

December 13, 2013 3:18 pm | by Alan Grau, President and Co-Founder, Icon Labs | Articles | Comments

The FDA and Department of Homeland Security recently issued an alert urging medical device makers and medical facilities to upgrade security protections to protect against potential cyber threats. This was issued in response to an ICS-CERT...

AdvaMed Applauds FDA User Fee Sequester Relief, Device Tax Repeal Language in Budget Deal

December 13, 2013 12:44 pm | by AdvaMed | News | Comments

Stephen J. Ubl, president and CEO of the Advanced Medical Technology Association (AdvaMed), issued the following statement today on the bipartisan federal budget agreement for fiscal years 2014 and 2015. “AdvaMed commends Chairmen Patty...

Nipple Aspirate Test Is No Substitute for Mammogram

December 13, 2013 11:33 am | by FDA | News | Comments

Many women admit that getting a mammogram is no fun, and may wish there was an easier, more comfortable way to screen for breast cancer in its earliest and most treatable stages. Some companies today are promoting a test in which a breast...

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