Medical Device News (FDA)
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 | 2 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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EU Looks to Tighten Medical Device Safety With Implant Registry
April 30, 2012 | No comments
In the wake of high-level scandals in the EU, including the Poly Implant Prothese (PIP) breast implant snafu and the metal-on-metal hip …
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FDA Strengthens International Collaboration to Ensure Quality, Safety of Imported products
April 26, 2012 | No comments
The FDA’s Global Engagement Report shed light on the volume of imported food, medical devices, and pharmaceuticals and outlines the measures taken …
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