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

Aug 15th, 2011 | By | Category: FDA, Media Reports

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 Medicine report (here) that has the medical device industry up in arms. It calls for scrapping the 510(k) clearance process and starting over. While some medical devices such as Class III (high risk) must provide scientific evidence through clinical trials of safety and effectiveness, other manufacturers merely exchange paperwork and claim their device is substantially equivalent to another device, a predicate, already cleared by the FDA.

If the FDA decides as a compromise position to create a moderate risk category with different qualifications for approval it no doubt would slow the entry of new medical devices into the marketplace and increase investment dollars.

Morningstar recently cut the fair value estimates of Stryker and Zimmer by about 5% each due to the increased scrutiny expected from regulators following the IOM recommendations.

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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.