Saturday 19 August 2017

Public Awareness

FDA Issues Final UniqueDevice Identification System (UDI) Rule

September 20, 2013 | No comments

Over a year since the draft rule was release the U.S. FDA on Friday issued a long-awaited rule requiring companies […]

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ANVISA Calls Off Strike

September 10, 2012 | No comments

ANVISA, Brazil’s medical device market regulator, called off a  strike that began in July. The decision to strike jeopardized foreign manufacturers’ importation […]

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FDA Commissioner: Device Approvals Process Set to Become Less Burdensome

August 24, 2012 | No comments

The head of the FDA, Commissioner Margaret Hamburg, “sounds an optimistic tone” claiming approval process for medical devices is about to become considerably […]

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Brazilian Regulators Go On Strike – ANVISA

August 3, 2012 | 1 comment

In mid-July Brazilian government officials, including those at the regulatory agency ANVISA, walked-out on strike, leaving the agency critically under-staffed. As […]

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FDA Issues Warning About Implantable Device

July 2, 2012 | No comments

The FDA issued a warning on Friday (June 29, 2012) regarding an implantable medical device manufactured by Covidien Plc subsidiary […]

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Moog Medical Devices Group Announces Voluntary Recall Of Select Curlin Administration Sets Due To Possible Health Risk

May 23, 2012 | No comments

From the FDA: May 22, 2012 – Salt Lake City, UT–Moog Medical Devices Group (MMDG) is issuing a voluntary recall […]

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Senators Seek to Improve Safety of Children’s Medications and Medical Devices

April 18, 2012 | No comments

A bipartisan team of Senators announced today new legislation aimed at improving the safety of children’s medications and medical devices. The bill introduced today […]

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Choking Hazard and Serious Injuries with the Spinbrush line of Powered Toothbrushes

March 21, 2012 | No comments

The FDA updated the Agency’s safety notice on a popular line of Spinbrush toothbrushes. The FDA said it was aware of […]

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IRS Issues Regulations on $20 billion Medical Device Tax

February 6, 2012 | No comments

Proposed regulations from the IRS on the 2.3% excise tax on medical devices, designed to generate $20 billion as part […]

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FDA and Industry Reach Agreement in Principle on Medical Device User Fees (MDUFMA)

February 1, 2012 | No comments

The FDA announced today that it reached an agreement on the third re-authorization of a medical device user fee program. The news follows the […]

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