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MDUFA

Update: 2012 Medical devices safety law pros and cons

Many of us like to think we could live forever. And with today’s technology, a medical device – hip replacement, heart valve, artificial knee – seems to put ‘forever’ a lot closer within reach.

Categories: Drugs, Hip and Knee Replacement
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Medical devices will begin getting special codes to help improve patient safety

FDA is developing a system to identify each medical device with a special code to help notify patients of recalls and other problems under a new rule proposed by the FDA.

Categories: Drugs, Hip and Knee Replacement
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Fact Sheet: Medical Device User Fee Amendments of 2012

List and brief description of medical device amendments contained in the FDA Safety and Innovation Act.

Categories: Drugs, Hip and Knee Replacement
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FDA Proposes Unique Device Identification Regulations for Medical Device

New system could help consumers of implantable life-sustaining devices access recall and other safety information about their specific device with a unique identifier system.

Categories: Drugs, Hip and Knee Replacement
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FDA user fee bill passes Senate, 92-4

Next stop-the President.

Categories: Drugs, Hip and Knee Replacement
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Hip, Hip, Delay

Metal hip hearing comes after passage of the FDA user fee bill which fails to address inadequate safety testing crucial to safe hip implants.

Categories: Drugs, Hip and Knee Replacement
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J&J Sold Vaginal Mesh Implant After Sales Halt Ordered

On June 5, J&J said it will stop selling four vaginal mesh implants including the Prolift in response to lawsuits. The company will not withdraw the Prolift before its “planned discontinuation” of the mesh products over the next three to nine months.

Categories: Drugs, Hip and Knee Replacement
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House rushes through approval of new PDUFA legislation

Next stop-the Senate and then the President’s desk.

Categories: Drugs, Hip and Knee Replacement
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#SPPChat: What Consumers Need to Know About Medical Device User Fee Bills

The intent of our Twitter chat on May 17 was to debunk industry claims about the FDA’s device approval process and explain what consumers really need to know about the medical device user fee bills.

Categories: Drugs, Hip and Knee Replacement
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Consumers demand safer medical devices

To make sure elected officials hear from Americans who’ve been harmed by outdated safety laws, Consumers Union’s Safe Patient Project brought 10 activists from seven states to Washington D.C. to share their medical device experiences and demand improvements. And it had a huge impact!

Categories: Drugs, Hip and Knee Replacement
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