FDA News

/FDA News

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 Read more

By | 2018-07-16T08:53:17+00:00 July 10th, 2018|FDA News|4 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 Read more

By | 2018-06-05T11:11:01+00:00 April 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 Read more

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

FDA Archived Material on Pelvic Mesh

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 Read more

By | 2017-10-10T17:39:34+00:00 October 10th, 2017|FDA News|13 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, Read more

By | 2017-09-18T00:24:03+00:00 September 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 Read more

By | 2017-04-20T10:36:33+00:00 April 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 Read more

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

New FDA Head Selected by President

Scott Gottlieb, M.D. Food Safety News 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 Read more

By | 2017-03-16T14:08:23+00:00 March 14th, 2017|FDA News|9 Comments

FDA: Lapdog Enforcement on Reporting Adverse Events

Lapdog, Portrait of Woman in Red, Agnolo Bronzino, 1532, Tuscan School, WikiCommons 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 Read more

By | 2017-03-07T10:44:31+00:00 March 7th, 2017|FDA News|7 Comments