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FDA Convenes Panel on POP Mesh in February 2019

Mesh Medical Device News Desk, November 22, 2018 ~ The FDA continues to explore what went wrong with mesh for pelvic organ prolapse and will rely on the public and experts to weigh in on February 12, 2019.  The U.S. Food and Drug Administration has slowly reacted to events concerning [...]

By |2019-02-11T13:40:40+00:00November 22nd, 2018|FDA News, News|4 Comments

Conflicts of Interest in FDA Expert Panels

Mesh Medical Device News Desk, November 6, 2018 ~ Expert Panels often decide to approve drugs and devices, but how objective are the panelists and do conflicts make a difference?  A report in Science Magazine (here) has peeled back to revelations of the conflict of interests that exist among experts who advise [...]

By |2018-11-07T10:53:19+00:00November 6th, 2018|FDA News|4 Comments

30 Months is Up! POP Mesh is Officially High Risk, Too Late for Many

Prolift for POP repair Mesh Medical Device News Desk, July 10, 2018 ~ Pelvic Organ Prolapse (POP) polypropylene mesh, that has injured so many, has just suffered another blow. After an initial announcement and a 30 month waiting period, finally this month, the FDA has officially reclassified POP [...]

By |2018-10-22T17:32:39+00:00July 10th, 2018|FDA News|7 Comments

FDA’s 510(k) Clearance Does NOT Lead to Safer Gyn Medical Devices

Mesh Medical Device News Desk, April 11, 2018 ~ The Food and Drug Administration's 510(k) clearance process for medical devices has been called a fast-track to market clearance process. This study reveals it does not lead to safer gynecologic medical devices. FDA Approval of Gynecologic Medical Devices Image: Desara mesh by [...]

By |2018-06-05T11:11:01+00:00April 11th, 2018|FDA News|0 Comments

FDA Finds No Prob with Boston Sci Chinese Counterfeit Mesh

Marlex from China Mesh Medical Device News Desk, November 7, 2017 ~ It's been more than a year since it was notified, but now the U.S. Food and Drug Administration (FDA) says there are no worries with the pelvic mesh made from raw polypropylene sourced under questionable circumstances [...]

By |2017-12-31T18:20:12+00:00November 7th, 2017|FDA News|22 Comments

FDA Pilot Program Helps Manufacturers Streamline Approval of Medical Devices

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, [...]

By |2017-09-18T00:24:03+00:00September 18th, 2017|FDA News|5 Comments

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

Dr. Jeffrey Shuren, CDRH 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 [...]

By |2017-04-20T10:36:33+00:00April 20th, 2017|FDA News|4 Comments

Trump’s FDA Pick Grilled on Priorities, Conflicts

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 [...]

By |2017-04-06T09:30:26+00:00April 6th, 2017|FDA News|6 Comments