Wednesday 16 April 2014

Medical Device News (FDA)

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Shutdown Delays Medical Device Approvals (510(k)s)

October 4, 2013 | No comments

As the shutdown continues the impact continues to be felt.  Some disruptions are expected, but given the broad and general […]

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FDA Issues Final UniqueDevice Identification System (UDI) Rule

September 20, 2013 | 1 comment

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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Looking Before Leaping into Latin America – Registration Holders

December 3, 2012 | No comments

Not long after successfully selling a medical device in the US (or perhaps even the EU) manufacturers and developers look to expand […]

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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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Guest Editorial: Rebuttal to FDA’s Internal Report on EU Medical Device Regulation

July 24, 2012 | No comments

Guest Editorial from Robert Packard, Sr. Manager, Regulatory Affairs at Delcath Systems, Inc.: In February, at a press conference in Brussels, […]

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FDA Unveils Proposed Device Identification System, New Database

July 3, 2012 | 4 comments

The FDA has released a proposed rule that requires most medical devices distributed in the United States carry a unique […]

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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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