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Tag Archives: IOM


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…]

Changes Are Afoot in U.S. Medical Device Regulations, Morningstar, August 15, 2011

By Mesh Medical Device Newsdesk |

This excellent article by Morningstar reminds us that the Food and Drug Administration (FDA) has been reviewing the regulatory process that allows most medical devices to make their way into the marketplace and the agency plans to have new changes in place by October. This is sparked by the July release of the Institute [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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FDA seeks more industry opinion about Device approval process, Star Tribune, August 2, 2011

By Mesh Medical Device Newsdesk |

The medical device industry is very concerned following an Institute of Medicine report that the fast-track system for getting devices on the market should be scrapped, reports the Twin Cities Star-Tribune. Dr. Jeffrey Shuren, who heads the FDA’s device division flew to attend a town hall meeting  with executives to assure them it might [continue reading…]

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