Posts Tagged ‘ medical device industry ’

Senate Passes FDA Funding Bill Minus Major Patient Safety Provisions

May 24th, 2012 | By
Senate Passes FDA Funding Bill Minus Major Patient Safety Provisions

May 24, 2012 ~ The U.S. Food and Drug Administration (FDA) is one step closer to being funded for the next five years in a bi-partisan vote considered good for the FDA and industry – but what about patients? The Food and Drug Administration Safety and Innovation Act passed on an unusual bi-partisan vote,  96-1,
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Michigan Lawmaker Wants FDA Promoting Jobs, Industry

Apr 20th, 2012 | By
Michigan Lawmaker Wants FDA Promoting Jobs, Industry

April 20, 2012 ~ Ask most Americans and they would say that the role of the U.S. Food and Drug Administration (FDA) is to protect us from unsafe food, medications and medical devices. Congressman Mike Rogers (R-MI) would like to expand the role of the FDA to include jobs promotion and growth for industry, a
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Media Reports on Money, Muscle, and Medical Devices

Nov 14th, 2011 | By
Media Reports on Money, Muscle, and Medical Devices

NOVEMBER 14, 2011 – Former Saturday Night Live comedian turned U.S. Senator, Al Franken represents Minnesota and with Minneapolis a hub of the medical device industry, he is doing all he can for his constituents. Share this:



Changes Are Afoot in U.S. Medical Device Regulations, Morningstar, August 15, 2011

Aug 15th, 2011 | By

This excellent article by Morningstar reminds us that the Food and Drug Administration (FDA) has been reviewing the regulatory process that allows most medical devices to make their way into the marketplace and the agency plans to have new changes in place by October. This is sparked by the July release of the Institute of
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510(k) Reform: Minnesota Congressional Delegation Lines up in Opposition, Mass Device, August 3, 2011

Aug 11th, 2011 | By
510(k) Reform: Minnesota Congressional Delegation Lines up in Opposition, Mass Device, August 3, 2011

Sens Amy Kloubechar (D-Minn.), Al Franken (D-Minn.) and Rep. Erik Paulsen (R-Minn) reject calls by the Institute of Medicine to kill the 510(k) program that allows medical devices on the market without premarket approval. In a joint statement the lawmakers rejected a July 2011 Institute of Medicine findings that the FDA should scrap the 510(k)
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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.