Free Case Evaluation
Connect
With Us

Category Archives: FDA News

FDA Archived Material on Pelvic Mesh

By Mesh Medical Device Newsdesk |

Mesh Medical Device News Desk, October 10, 2017 ~ The U.S. Food and Drug Administration has been looking at the issue of pelvic or transvaginal mesh for more than ten years now. Though slow to act to recall mesh, to follow up on ordered studies, to create a medical device registry, there have been [continue reading…]

FDA Pilot Program Helps Manufacturers Streamline Approval of Medical Devices

By Mesh Medical Device Newsdesk |

Mesh Medical Device News Desk, September 18, 2017 ~ The FDA spends much of its resources working with device and drug manufacturers to help ease their way to market. Here is another example of a newly announced pilot program that will help do just that.  Unlike drugs, high-risk medical devices, even some permanently implanted, [continue reading…]

Does the FDA’s MAUDE Work?

By Mesh Medical Device Newsdesk |

Mesh Medical Device News Desk, May 17, 2017 ~ Does MAUDE work? MAUDE is the FDA’s central database that’s supposed to identify problems with medical devices that are on the market. Washington University did a review and found it was inadequate.  Printed on the website of Society of American Gastrointestsinal and Endoscopic Surgeons (SAGES),is [continue reading…]

FDA’s Shuren on Tightening Future FDA Review of High-Risk Devices

By Mesh Medical Device Newsdesk |

Mesh Medical Device News Desk, April 20, 2017 ~ FDA’s Jeff Shuren writes about how to serve two masters, public safety and the need of manufacturers for fast access to the marketplace for high-risk devices. Can anyone serve two masters? For seven years, Dr. Jeffrey Shuren has headed the Center for Devices and Radiological Health [continue reading…]

Trump’s FDA Pick Grilled on Priorities, Conflicts

By Mesh Medical Device Newsdesk |

Mesh Medical Device News Desk, April 6, 2017 ~ President Trumps selection of Scott Gottlieb reveals a health industry insider full of potential conflicts.  Dr. Scott Gottlieb was grilled during a confirmation hearing on Capitol Hill Wednesday and said his first priorities will include the opioid crisis. Gottlieb is a medical doctor who turned [continue reading…]

New FDA Head Selected by President

By Mesh Medical Device Newsdesk |

Mesh Medical Device News Desk, March 14, 2017 ~ According to the New York Times, Mr. Trump’s latest pick to head the FDA could undo decades of drug safeguards. Dr. Scott Gottlieb, M.D., 44, has ties to pharmaceutical and biotech companies and is a partner at a large venture capital fund, which funds medical [continue reading…]

FDA: Lapdog Enforcement on Reporting Adverse Events

By Mesh Medical Device Newsdesk |

Mesh Medical Device News Desk, March 7, 2017 ~ In mild mannered newly-issued language, The U.S. Food and Drug Administration (FDA) recommends that medical device manufacturers report adverse events to the agency, but it’s not legally enforceable.    This new regulation issued November 2016, updates 20-year-old regulations for medical device reporting (MDR). Guidance for [continue reading…]

GAO Report on Power Morcellators

By Mesh Medical Device Newsdesk |

Mesh Medical Device News Desk, February 10, 2017 ~ The GAO report on power morcellators finds there were 25 requests to market new power morcellator devices submitted to the FDA over a 23 year period, all were cleared for the marketplace.    The U.S. Government Accountability Office (GAO) has just issued a report (here) [continue reading…]

FDA Finally Reclassifies Pelvic Mesh Tools

By Mesh Medical Device Newsdesk |

Mesh Medical Device News Desk, January 16, 2017~ Pelvic mesh tools used to place and affix transvaginal mesh had been a low-risk FDA category alongside Band-aids. Because of injuries, it’s been placed in a class II or moderate-risk category.  Tools used to place transvaginal mesh have been found to cause injuries in up to [continue reading…]

FDA Pelvic Mesh Data – Are Thousands of Deaths Not Being Reported?

By Mesh Medical Device Newsdesk |

Mesh Medical Device News Desk, December 5, 2016 ~ A former FDA IT project manager left the agency to focus on patient safety and the numbers needed for true patient advocacy. Imagine 5.6 million pieces of data collected by the U.S. Food and Drug Administration (FDA) concerning adverse events, the FDA term for complications. [continue reading…]

© 2016 - 2017 Mesh Newsdesk. All rights reserved.
This is a Sundown Legal Marketing law firm website.