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Tag Archives: AdvaMed

Consumers Union Safe  Patient Project

FDA Funding: Medical Device Makers and Lap Dog Watchdogs

By Mesh Medical Device Newsdesk |

Mesh Medical Device News Desk, August 29, 2016 ~ The medical device industry and the U.S. Food and Drug Administration (FDA) have reached tentative agreement on $1 billion in funding from the very industry it regulates. The Medical Device User Fee Agreement IV (MDUFA IV) will be delivered to Congress in January. It represents [continue reading…]

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FDA Considers Revising 510(k), Industry Balks

By Mesh Medical Device Newsdesk |

June 13, 2013~ “External stakeholders.” That is what the FDA calls medical device manufacturers who also  have a decisive role in shaping the regulations they fall under. Thursday, June 13, the FDA met with stakeholders to discuss modifying the 510(k) approval process. (here) About 90 percent of the 4,000 medical devices approved by the [continue reading…]

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C.R. Bard Lawsuits: Rulings Reveal Company Secrets

By Mesh Medical Device Newsdesk |

May 23, 2013 ~ Buried inside some rather routine motions filed in the upcoming federal lawsuits filed in federal court in Charleston, West Virginia are some company secrets that C.R. Bard would rather keep secret. In Order #77 Plaintiffs want to take the deposition of C.R. Bard executives Roger Darois and Dan LaFever. The [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 Safe Patient project logo 218

Consumer Reports Campaign email Alerts Million About Defective Medical Devices

By Mesh Medical Device Newsdesk |

MARCH 12, 2012 ~ How bad are medical devices approved by the U.S. Food and Drug Administration? Reuters reports (here) that Consumer Reports believes they are very bad. The president of the 76-year-old publication wrote in an email to 1 million subscribers this year that, “The implant that fixed your knee or your heart [continue reading…]

WLF

FDA Denies Legal Group Seeking to Ban IOM Recommendations

By Mesh Medical Device Newsdesk |

March 7, 2012 ~ Bloomberg BNA reported (here) that the Washington Legal Foundation (WLF), had its petition rejected by the Food and Drug Administration February 21 after the industry-tied group tried to have the recommendation of an expert scientific panel barred from FDA consideration and implementation. The WLF is made up of corporate inside-the-beltway [continue reading…]

Dr. Jeffrey Shuren, CDRH

FDA Misses Deadline to File Financials for Review

By Mesh Medical Device Newsdesk |

The U.S. Food and Drug Administration (FDA) was supposed to submit a new agreement to lawmakers on  January 15, concerning how much funding it will need next year to review medical devices and conduct product reviews. Bloomberg reports (here) no new agreement was filed – the FDA essentially missed its deadline. That may hurt [continue reading…]

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Industry Influence – Lobbying Doesn't Come Cheap

By Mesh Medical Device Newsdesk |

AdvaMed Advanced Medical Technology Association or AdvaMed (here) calls itself the world’s largest medical technology association. In other words, it is the lobbying arm of the medical device industry and in terms of surgical mesh, there is a lot at stake.

Dr. Jeffrey Shuren, CDRH

How to Speed Up Approval of Medical Devices?

By Mesh Medical Device Newsdesk |

OCTOBER 3, 2011 –  How to speed up the approval of a medical device that cannot claim it is substantially similar to one already on the market under 510(k)? On Friday, September 30, the Food and Drug Administration released a long-awaited proposed revision to the 510(k) clearance process that could speed up product reviews [continue reading…]

Study of Medical Device Rules Is Attacked, Unseen, New York Times, July 27, 2011

By Mesh Medical Device Newsdesk |

Allies of the medical device industry criticized an Institute of Medicine report, to be released July 29, that says the approval process for a wide range of medical devices such as hip implants, hospital pumps, surgical mesh and external heart defibrillators is deeply flawed, is injuring patients and causing numerous injuries, reports the New [continue reading…]

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