Posts Tagged ‘ MDUFA ’

FDA Follows Industry Lead to Shorten Time to Market

Oct 31st, 2012 | By
2 TYPES OF HIP  replacement total and resurfacing

October 30, 2012 ~    The FDA has issued the new rules for medical device makers to speed up the time it takes for medical devices to make it to market. Earlier this year industry agreed to pay $595 million over 5 years to the FDA as part of its operating budget. In exchange, the
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MDUFA for Another Five Years

Aug 7th, 2012 | By
FDA logo 152

August 6, 2012 ~ The U.S. Food and Drug Administration (FDA) has a renewed source of funding for the review of medical devices, at least for the next five years. On October 1, 2012 the Medical Device User Fee Amendments of 2012 or MDUFA III will go into effect. It will expire October 1, 2017.
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FDA’s Shuren Tells Industry Medical Device Reviews are Faster, More Efficient

Jun 14th, 2012 | By
Dr. Jeffrey Shuren, CDRH

If you ask the public, most say they want safer medical devices, not more of them.  If you ask the patients profiled in Mesh Device News Desk (MDND) they’d say they wished they’d known that the medical devices they received had come with a prominent warning that would have told them what they were in
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Senate Passes FDA Funding Bill Minus Major Patient Safety Provisions

May 24th, 2012 | By
Senate on mdufa  200

May 24, 2012 ~ The U.S. Food and Drug Administration (FDA) is one step closer to being funded for the next five years in a bi-partisan vote considered good for the FDA and industry – but what about patients? The Food and Drug Administration Safety and Innovation Act passed on an unusual bi-partisan vote,  96-1,
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Politico Ad: Consumers Union Warns the FDA Cannot Protect Patients

May 22nd, 2012 | By
Consumers Union ad in Politico

May 22, 2012 ~ The U.S. Food and Drug Administration (FDA) has as its mission the protection of the American people from dangerous consumer products such as food, pharmaceuticals and medical devices – right? Consumers Union in a recent poll found most Americans  believe safety is the FDA’s mission, so why then is the consumer
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FDA Closer to Funding Goals – Where is Patient Safety?

May 14th, 2012 | By
Rep. Edward Markey

On May Tuesday, May 8, a House subcommittee unanimously voted to approve its version of the Medical Device User Fee Act (MDUFA) which funds the U.S. Food and Drug Administration’s oversight of medical devices for the next five years. However, the House voted 46-0 without approving legislation that would protect Americans from defective medical devices
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Michigan Lawmaker Wants FDA Promoting Jobs, Industry

Apr 20th, 2012 | By
Rep. Mike Rogers (R-MI)

April 20, 2012 ~ Ask most Americans and they would say that the role of the U.S. Food and Drug Administration (FDA) is to protect us from unsafe food, medications and medical devices. Congressman Mike Rogers (R-MI) would like to expand the role of the FDA to include jobs promotion and growth for industry, a
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FDA: What is MDUFA? Hearings on $595 Million and What Industry Wants

Feb 14th, 2012 | By
Dr. Jeffrey Shuren

February 14, 2012 ~ What is MDUFA? The Medical Device User Fee and Modernization Act shortened from MDUFMA. Enacted in 2002 and again in 2007 it authorized the FDA to collect a user fee from industry to review medical devices before they go on sale. MDUFA in 2010 funded about 20 percent of the medical
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Must Watch Live Feed: Hearings on Mesh, Medical Device Budget Pits Patient Safety v. Industry

Feb 13th, 2012 | By
tv  200

A must watch show How to Watch:  Go to  (link will show up when gavel begins hearing, live feed)  Hearing: “Reauthorization of MDUFA: What It Means for Jobs, Innovation and Patients” When: The Subcommittee on Health has scheduled a hearing on Wednesday, February 15, 2012, at 10:00 a.m. in room 2322 of the Rayburn
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Consumers Union’s Safe Patient Project Brings Eight Activists to Congress

Feb 6th, 2012 | By
CU's Safe Patient Project

February 6, 2012 ~ Consumers Union is bringing eight patient activists to Washington, D.C. to meet with lawmakers and press for strengthened medical device oversight. The timing is important. The Food and Drug Administration’s budget will be determined by the Medical Device User Fee Act (MDUFA) and the medical device industry is pushing for faster
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