Monday 24 April 2017

Medical Device News (FDA)

PIPScandalReform

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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FDAUpdate

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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FDAEMA

Report: Internal FDA Reports Slams European Regulation of Medical Devices as Ineffective

April 24, 2012 | 2 comments

The FDA has criticized Europe’s review process for medical devices in an unreleased internal report, claiming the failure of some […]

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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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BiometIncbribery

SEC Charges Medical Device Company Biomet with Foreign Bribery

April 3, 2012 | No comments

The Securities and Exchange Commission announced today that it charged Warsaw, Indiana based medical device company Biomet Inc. with violating the Foreign […]

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FDAUpdate

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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spinbrushrecallsafety

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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MedsiderEUapproval

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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Acclarent Inspira AIR Balloon Dilation System Recall

Acclarent Inspira AIR Balloon Dilation System Recalled

March 13, 2012 | No comments

The FDA issued a recall for the Acclarent Inspira AIR baloon dilation system due to the products failure to function […]

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GlobusMedicalFDASettlement

FDA reaches $1 million Settlement with Pennsylvania Medical Device Firm

February 29, 2012 | No comments

The FDA Announced today that it reached a settlement with Globus Medical Inc. for the distribution of unapproved medical devices. The FDA and Globus […]

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