FDA Revamps Medical Device Approval

The 510(k) program overhaul aims to facilitate innovation, streamline the review process, and protect patient safety.
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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 The executive orders also calls for a government-wide review of the rules already on the books to remove outdated regulations that "stifle job creation and make our economy less competitive," the president said in an editorial he wrote for Tuesday's Wall Street Journal.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.