Shuren to MN device industry: Reviewers will undergo training, MedCity News, August 3, 2011

/, Media Reports/Shuren to MN device industry: Reviewers will undergo training, MedCity News, August 3, 2011

Shuren to MN device industry: Reviewers will undergo training, MedCity News, August 3, 2011

Flexible Endoscope medical device

Minnesota is a mecca for medical device manufacturers, so Dr. Jeffrey Shuren, who heads the device division of the Food and Drug Administration (FDA) made it one of his first stops after the second warning about synthetic surgical mesh by the FDA, and an Institute of Medicine criticism of the 510 (k) process that allows devices to be marketed bypassing clinical trials.

The medical device industry is understandably nervous.

Med City News reports in this article, here, that the FDA does not have enough experienced reviewers to determine which medical devices should be approved. At the invitation of a Minnesota medical device trade group, Shuren assured the group that the FDA will begin a reviewer certification and training program starting in September. This will be a new program that “should help in the certification of medical devices.”

Dr. Shuren seemed reluctant to use a third-party reviewer program, reports the paper.

MedCity News followed-up with this article on a private-public partnership suggested by the medical device community to Dr. Shuren during his visit. It will be focused on “regulatory science” which uses tools to evaluate medical devices and allows more access by the industry into the regulatory process.

 

 

 

 

 

By | 2011-08-03T19:22:36+00:00 August 3rd, 2011|FDA News, Media Reports|0 Comments

About the Author:

I’m National News Editor, Jane Akre and I began Mesh Medical Device News Desk aka Mesh News Desk (MND) in the summer of 2011 just after the Food and Drug Administration issued an explicit warning to the public that complications associated with surgical mesh used for prolapse repair (POP) and incontinence (SUI) are NOT rare! That was the starting point for the litigation you see today and thousands of lawsuits have been filed by women whose lives have been altered, some permanently, by the use of this petroleum-based product.

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