FDA solicits comment on custom device review

November 23, 2012 by MassDevice staff

The FDA opens up for public comment its custom medical device review protocols, asking interested parties to offer perspective on a system that has had some recent snafus.

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The FDA is seeking public comment on its custom medical device exemption criteria following some changes implemented through the FDA Safety & Innovation Act, which was signed into law earlier this year.

The proposed rules include 4 main tenets for fitting the definition of a custom medical device as well as limits on annual production and use.

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The federal watchdog agency is seeking "information on and examples of appropriate uses" of the custom medical device exemption system, especially input from patients, manufacturers, dentists and physicians on circumstances in which they have or would like to use custom devices.

The FDA's custom device criteria, according to a federal notice, include exemption for a device which fits the following definitions:


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