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FDA to Improve Most Common Review Path for Medical Devices
Date:1/19/2011

, CDRH also asked the independent, nonprofit Institute of Medicine to study the program.  That review is still underway.

In a transparent effort, CDRH sought public input during both the development and review of the two internal reports. The center held two public meetings in the Washington area and separate "town hall" meetings in Minneapolis, Boston and Los Angeles. The FDA also received 76 written comments to three public dockets from industry members, health care 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 for a public meeting in April to seek additional feedback on two other recommendations.

Dr. Shuren announced the action plan today in an open letter to the public. "We look forward to implementing these changes in support of our overall mission: improving the health of the American public," he said.

For more information

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHReports/ucm239448

Media Inquiries: Karen Riley, 301-796-4674, karen.riley@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA




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SOURCE U.S. Food and Drug Administration
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