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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 |2017-09-18T00:24:03-04:00September 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 |2017-04-20T10:36:33-04:00April 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 |2017-04-06T09:30:26-04:00April 6th, 2017|FDA News|6 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 [...]

By |2017-03-07T10:44:31-05:00March 7th, 2017|FDA News|7 Comments

FDA Finally Reclassifies Pelvic Mesh Tools

Surgical tools, FDA 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 [...]

By |2017-01-23T12:30:21-05:00January 16th, 2017|FDA News|16 Comments

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

Madris Tomes, Device Events Mesh Medical Device News Desk, December 5, 2016 ~ A former FDA IT project manager left the agency to focus on patient safety and on finding the numbers needed for true patient safety and advocacy. Imagine 5.6 million pieces of data collected by the [...]

By |2019-02-14T12:38:19-05:00December 5th, 2016|FDA News|18 Comments

Essure Birth Control Gets FDA’s Strongest Warning

Essure, ABC, Tampa Mesh Medical Device News Desk, November 15, 2016 ~ The U.S. Food and Drug Administration has approved a label change on Essure Birth Control that includes the strongest warning a device can carry.  Known as a Black Box warning, the label change will now clearly warn [...]

By |2016-11-15T12:43:23-05:00November 15th, 2016|FDA News|5 Comments