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FDA Revamps Medical Device Approval

The 510(k) program overhaul aims to facilitate innovation, streamline the review process, and protect patient safety.

Health IT Boosts Patient Care, Safety
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The Food and Drug Administration unveiled Wednesday a plan to revamp its 510(k) program that medical device manufacturers use to clear their products before they can be marketed and sold to the public.

Many medical device manufacturers see the efficient running of the 510(k) program as pivotal to stimulating U.S. innovation, investment, and job growth in the medical device industry. The FDA's Center for Devices and Radiological Health (CDRH) uses the program to clear some 3,000 new medical devices for patients each year.

"Facilitating innovation is a critical part of the agency's responsibility to promote the public health, but this can happen only if the U.S. can support a robust, innovative, medical device industry," Jeffrey Shuren, director of FDA's center for devices and radiological health, said in a statement. "The steps we are announcing today remove roadblocks to innovation while protecting patient safety."

To facilitate innovation in medical devices, the FDA will:

-- Streamline the review process for innovative, lower-risk products, called the "de novo" process;

-- Publish guidance for industry to clarify when clinical data should be submitted to increase predictability and transparency;

-- Develop a network of external experts who can use their knowledge and experience to help the agency address important scientific issues regarding new medical device technologies; and

-- Establish a new Center Science Council of senior FDA experts within the agency's medical device center to assure more timely and consistent science-based decision making.

The FDA also announced that it will strengthen its capacity to examine and monitor the safety of medical devices once they are on the market and being used. It will establish a public database of important device information, such as medical device labeling and summaries of the basis for the FDA's decision to clear specific devices. It will also require a brief description of scientific information regarding the safety and effectiveness known to the manufacturer for select higher-risk devices on a case-by-case basis through device-specific guidance.

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