FDA taps Institutes of Medicine for $1.3 million 510(k) process audit

September 23, 2009 by MassDevice staff

The Food & Drug Administration tapped the Institutes of Medicine for a $1.3 million study of its 510(k) pre-market approval system for medical devices.

The FDA said the IOM examination will coincide with its own, internal investigation by the Center for Device and Radiological Health.

The IOM study will address two central questions, according to an FDA press release:

1. "Does the current 510(k) process optimally protect patients and promote innovation in support of public health?"
2. "If not, what legislative, regulatory, or administrative changes are recommended to achieve the goals of the 510(k) process?"

The review is slated to be finished in March, 2011. Other CDRH priorities, according to acting director Jeffrey Shuren, are an internal "task force" on the role of science in the watchdog agency's decision-making process; integrating the pre-market approval process and post-market monitoring; increase transparency; and clear procedures for resolving differences within the agency.

Part of the IOM review will involve a pair of public workshops during the next nine months.

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