FDA Revamps Medical Device ApprovalFDA Revamps Medical Device Approval

Health IT Boosts Patient Care, Safety

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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Changes to the 510(k) program are in keeping with the Obama administration's push to overhaul regulations that stifle innovation and business growth. On Tuesday President Obama signed an executive order requiring federal agencies to ensure that regulations protect safety, health, and the environment while advancing economic growth. The executive orders also calls for a government-wide review of the rules already on the books to remove outdated regulations that "stifle job creation and make our economy less competitive," the president said in an editorial he wrote for Tuesday's Wall Street Journal.

According to Shuren, the latest changes to 510(k) will result in "a smarter medical device program that supports innovation, keeps jobs here at home, and brings important, safe, and effective technologies to patients quickly."

In September 2009, CDRH set up two internal working groups to address concerns relating to the premarket notification process -- industry argued that the 510(k) process was unpredictable, inconsistent, and opaque, while consumers and healthcare professionals argued that the review process wasn't robust enough. At the same time, CDRH also asked the independent, nonprofit Institute of Medicine to study the program. That review is still underway and the findings are scheduled to be published in mid-2011.

In a transparency effort, CDRH sought public input during both the development and review of the two internal reports. The center held public meetings and the FDA received 76 written comments to three public dockets from industry members, healthcare professional organizations, consumer groups, patient groups, third-party payers, venture capital groups, agency staff, trial lawyers, foreign regulatory bodies, law firms, individual members of the public, consulting firms, and academic institutions.

The two working groups issued 55 recommendations in August 2010. After reviewing public comment, CDRH now intends to take 25 actions to improve the 510(k) program in 2011, including new guidance and enhanced staff training. CDRH also is giving the Institute of Medicine an opportunity to provide feedback on seven recommendations before making a final decision, and is planning to hold a public meeting in April to seek additional feedback on two other recommendations.