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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

GAO Report on Power Morcellators

Drs. Amy Reed and Hooman Noorchashm and children, from Philadelphia Magazine 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 Read more

By | 2017-02-10T13:47:57+00:00 February 10th, 2017|FDA News|2 Comments