U.S. FDA unveils device changes, defers big issues

WASHINGTON (Reuters) - The U.S. Food and Drug Administration unveiled steps aimed at streamlining the approval process used for most medical devices but deferred decisions on the most contentious issues.

The FDA said on Wednesday it would ask the Institute of Medicine for input on seven proposals, including creation of a new class of devices that would require more data to win approval.

The delay on the toughest issues was a win for the device industry, which worried the FDA would impose standards that would slow development of new products reviewed under an abbreviated process known as 510(k).

That approval pathway has drawn fire from critics who say it is too widely used and has allowed unsafe products to reach the market with little FDA review.

The FDA said it will impose 25 changes to the program in 2011, including streamlining the review process for some innovative, lower risk devices and creating an internal council to "assure timely and consistent science-based decision-making."

The steps will lead to "a smarter medical device program that supports innovation, keeps jobs here at home, and brings important, safe, and effective technologies to patients quickly," said Dr. Jeffrey Shuren, head of the FDA device center.

Medical devices range from simple bandages to complex implants such as pacemakers, stents, and artificial knees. The largest medical-device makers include Medtronic Inc., Johnson & Johnson, Boston Scientific Corp., and Abbott Laboratories Inc.

One consumer advocate said the FDA had moved away from more dramatic changes that would have helped patients in the face of industry lobbying.

"FDA has backed down on important safety measures that would have saved lives," said Diana Zuckerman, president of the National Research Center for Women & Families.

By Lisa Richwine

Last Updated: 2011-01-19 14:53:20 -0400 (Reuters Health)

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