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1/19/2011
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Obama Orders FDA To Streamline Medical Tech Regulations

Executive order signed the same day PricewaterhouseCoopers reports that the U.S. is losing ground on medical device innovations, partially due to the agency's cumbersome and costly approval process.

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On the same day that President Barack Obama chided regulatory agencies like the Food and Drug Administration for developing regulations that interfere "with the pursuit of progress and the growth of our economy," PriceWaterhouseCoopers (PwC) published a report that found emerging markets led by China, India, and Brazil are chipping away at America's lead in medical technology innovation, in part, because the FDA's 510 (k) medical device approval program is cumbersome and costly.

In an article he penned for Tuesday's Wall Street Journal, President Obama said the FDA will outline new efforts to improve the process for approving medical devices. The president also signed an executive order on Tuesday requiring federal agencies to ensure that regulations protect safety, health, and the environment while advancing economic growth.

Anand Iyer, president and chief operating officer of WellDoc, a telehealth company that recently received FDA 510 (k) clearance for its WellDoc DiabetesManager system, said the time has come for the FDA to develop a medical device approval program that demonstrates the balance of innovation and safety that the president seeks.

"WellDoc applauds President Obama's executive order, which will help the FDA ensure safety and efficacy, while fulfilling their complete mission of advancing public health. The safe and accelerated approval of new genres of medical devices -- especially those which enable more effective and cost-efficient healthcare -- drives our nation's innovation potential and global competitive advantage," Iyer told InformationWeek.

The FDA's 510 (k) clearance program, which approves medical devices for sale in the United States, is a key component that PwC examined to determine U.S. competitiveness in medical technology innovation.

According to PwC's report, "Medical Technology Innovation Scorecard: The Race for Global Leadership," U.S. success in medical technology in previous decades has been due, in part, to the global leadership the FDA has displayed in establishing standards and guidelines to ensure product safety, but during the last decade the FDA has lost its ability to inspire confidence among medical technology executives.

"In a recent survey of 50 life sciences companies (including 19 companies developing medical device or diagnostic products), PwC found that respondents experienced frequent problems in gaining product approvals, even to the point of FDA changing its position during the application review process. Forty percent of survey participants agreed that FDA denied some product approvals primarily because of inadequate review resources," the report said.

Another concern is the cost of applying for 510 (k) product approvals, the report said. "The industry also has expressed concern about FDA's effort to revamp its 510 (k) process, through which 90% of devices gain U.S. approval. The cost of a 510 (k) application ranges from $1 million to $50 million, compared with $50 million to $150 million for higher-risk device applications. The industry is concerned that additional 510 (k) requirements calling for more extensive clinical or manufacturing data could drive up costs and lengthen time to market," the report concluded.

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