FDA and Med Device Makers Make it Official

Dec 8th, 2011 | By | Category: FDA

Dr. Jeffrey Shuren, CDRH

by Jane Akre// DECEMBER 7, 2011

//Shuren Signs Memo of Understanding//

Minnesota loves its medical device industry. Even Senator Al Franken (D-MN) who used to parade on Saturday Night Live with a satellite dish on his head as a roving comedic newsman, has gotten pretty serious when it comes to promoting legislation to help Minnesota’s favorite industry. (see background story here)

Now the U.S Food and Drug Administration (FDA) and the medical device industry are taking their love affair to the next level.

LifeScience Alley, (here), a professional organization of device makers from the Midwest, has created an official partnership with the FDA so together they can develop “regulatory science,” in other words, industry can help craft the regulations that cover….industry. See the press release here.

During Wednesday, December 7th LifeScience Alley’s Tenth Annual Conference & Expo, the President & CEO of LifeScience Alley and the BioBusiness Alliance of Minnesota signed a Memorandum of Understanding (MOU) to that effect.

The Center for Devices and Radiological Health (CDRH), which regulates medical devices under the FDA and director, Jeffrey Shuren signed the MOU at the conference where he was a scheduled speaker.

It’s been a rocky relationship. While the FDA takes criticism from industry for taking too long to approve medical devices, the med device industry has been known to rush products to the market before their time. See Patient Profiles on Medical Device News Desk.

Even the Archives of Internal Medicine (here) found that most of the medical devices that were fast-tracked to approval (for marketing not safety) and didn’t require human testing for safety were those most likely to be recalled in recent years.

Millions of Americans may be at risk for device-related injuries and recalls from high-risk devices that were cleared by FDA without any supporting clinical trial data,” reports Minnesota’s NPR station (here).

What the MOU will accomplish: 

“It recognizes that CDRH and the medical technology sector represented by LifeScience Alley have shared interests in further developing regulatory science and in enhancing the understanding of the safety, effectiveness, quality, and performance of devices. This agreement builds the foundation for specific projects that will improve the environment in which the medical device industry is operating, including a more formal partnership involving MedTech community members, University of Minnesota experts, and CDRH.”

Why Minnesota?

Minnesota claims to be the global center for medical device technology and is home to or has major facilities for 3M, American Medical Systems, Boston Scientific, Mayo Clinic, Medtronic, St. Jude Medical.

There are reportedly more than 400 FDA-registered medical device companies in MN with the highest medical device employment density in the United States. #

 

 

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2 Comments to “FDA and Med Device Makers Make it Official”

  1. Amy G says:

    Congrats to Dr. Shuren and the FDA ……the merge supports Merton’s Social systems theory of entropy and anomie.

    “When a system of cultural values extols, virtually above all else, certain common success-goals for the population at large while the social structure rigorously restricts or completely closes access to approved modes of reaching these goals for a considerable part of the same population,…deviant behavior ensues on a large scale.”-Merton

  2. DJ says:

    The fox is guarding the hen house! Disgusting and shameful! Shame on the FDA!

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We hope you find this a helpful resource. National News Editor, Jane Akre, began MDND with the hope of providing the latest news, information and perspective from the regulatory, industry and patient point of view, something that goes under-reported in much of the coverage of medical devices. The public is just now becoming aware that many devices do not undergo the same scrutiny as prescription drugs and are instead grandfathered in under an FDA loophole that has gone largely unchanged since the 1970s. As a result, patients become the post-market clinical trial subjects, and many suffer devastating and permanent injuries.