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Monday 30 November 2015

Device Approval

FSMA Comment Period.fw

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 | 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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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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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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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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Better Pharmaceuticals and Devices for Children Act

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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New FDA Guidance on Considerations Used in Device Approval, De Novo Decisions

March 28, 2012 | No comments

The U.S. Food and Drug Administration today published a first-of-a-kind guidance for medical device manufacturers, describing how the benefits and risks of […]

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Medside Interview – Should Medical Device Companies Pursue Regulatory Approvals in Europe Before the US?

March 18, 2012 | No comments

If you are interested in learning more about whether to pursure FDA or EU pre-market approval first, take a moment […]

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