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Tag Archives: MDUFA

2 TYPES OF HIP  replacement total and resurfacing

FDA Follows Industry Lead to Shorten Time to Market

By Mesh Medical Device Newsdesk |

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, [continue reading…]

FDA logo 152

MDUFA for Another Five Years

By Mesh Medical Device Newsdesk |

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, [continue reading…]

Dr. Jeffrey Shuren, CDRH

FDA’s Shuren Tells Industry Medical Device Reviews are Faster, More Efficient

By Mesh Medical Device Newsdesk |

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 [continue reading…]

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Senate Passes FDA Funding Bill Minus Major Patient Safety Provisions

By Mesh Medical Device Newsdesk |

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,  [continue reading…]

Consumers Union ad in Politico

Politico Ad: Consumers Union Warns the FDA Cannot Protect Patients

By Mesh Medical Device Newsdesk |

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 [continue reading…]

Rep. Edward Markey

FDA Closer to Funding Goals – Where is Patient Safety?

By Mesh Medical Device Newsdesk |

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 [continue reading…]

Rep. Mike Rogers (R-MI)

Michigan Lawmaker Wants FDA Promoting Jobs, Industry

By Mesh Medical Device Newsdesk |

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, [continue reading…]

Dr. Jeffrey Shuren

FDA: What is MDUFA? Hearings on $595 Million and What Industry Wants

By Mesh Medical Device Newsdesk |

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 [continue reading…]

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Must Watch Live Feed: Hearings on Mesh, Medical Device Budget Pits Patient Safety v. Industry

By Mesh Medical Device Newsdesk |

A must watch show How to Watch:  Go to www.energycommerce.house.gov  (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 [continue reading…]

CU's Safe Patient Project

Consumers Union's Safe Patient Project Brings Eight Activists to Congress

By Mesh Medical Device Newsdesk |

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 [continue reading…]

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