Medical Device News (FDA)
Hip Implants U.S. Rejected Sold Overseas
February 15, 2012 | No comments
One of the most frequent questions clients ask me is whether its faster or easier for a device to be …
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New Jersey Company Agrees to Halt Production of Unapproved Dental Devices
February 14, 2012 | No comments
The US Food and Drug Administration announced a consent decree with a NJ company to halt the production of an unapproved medical …
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EC’s Commissioner for Health and Consumer Policy Calls for Stricter Safety Controls, Postmarketing Surveillance for Medical Devices
February 10, 2012 | No comments
The European Commission’s (EC) Commissioner for Health and Consumer Policy John Dalli called for the EC to “look at the …
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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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Vitaflo USA Announces Nationwide Voluntary Recall of Renastart 14.11 oz (400g)
January 31, 2012 | No comments
The FDA released a voluntary recall notice from Vitaflo USA. Vitaflo USA is recalling Renastart 14.11 oz (400g) cans, Batch Number 12832 …
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Department of Justice Files Consent Decree of Permanent Injunction Against Ranbaxy
January 25, 2012 | No comments
An Indian generic drug maker faces liquidated damages and a permanent injunction under a DOJ consent decree filed today. Ranaxby, is accused …
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Perfect Image Solutions, LLC Issues Voluntary Recall – A Lesson in Reviewing Regulations Before Marketing and Selling
January 20, 2012 | 2 comments
Skipping the regulatory review of a new product to determine whether its FDA regulated comes with consequences as the FDA …
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EC Looking to Recommend Tougher Regulations on Medical Devices, More Member State Coordination
January 20, 2012 | No comments
New changes are emerging from the French scandal involving breast implants. The European Commission (EC) will investigate whether or not …
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Importance of MDR Reporting; J&J Delayed Reporting Insulin Pump Problems
January 11, 2012 | No comments
The Associated Press is reporting that the FDA has warned Johnson & Johnson that it could face fines and other sanctions …
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