IOM to examine FDA approval process for certain devices

The Institute of Medicine will undertake a $1.3 million review of the Food and Drug Administration’s approval process for certain new medical devices.

The study will examine the FDA notification process for new, low-risk medical devices that have the same use as existing devices and use similar technology or new technology that either does not raise any questions about safety and efficiency, or is at least as safe and effective as products already in the market. Among the medical devices to win approval under the review process this year: a liquid bandage, electronic blood pressure monitor and powder-free latex patient examination gloves.

The IOM, which was commissioned for the analysis, will consider how well the process protects patients and promotes innovation and what changes, if any, would improve results, according to an FDA press release. Meanwhile, the FDA Center for Devices and Radiological Health will undertake its own review “to evaluate and improve the consistency of FDA decision making”, according to the release.

Janet Trunzo, executive vice president of technology and regulatory affairs for the Advanced Medial Technology Association, in a written statement, urged the IOM to include experts in medical device innovation and regulation. Trunzo praised the FDA’s approval process as “well-defined, science-driven method” and said she believed the review would underscore strengths of the existing system.

The study’s results are expected to be released in March 2011.

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