FDA details medical devices approved through de novo fast-track

August 20, 2012 by MassDevice staff

The FDA updates its list of medical devices approved through the de novo review pathway, reserved for medical devices that are novel but represent low risks to patients.

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The FDA updated its reporting on its newly streamlined de novo medical device review pathway, detailing products the agency has cleared so far.

The update includes approval letters and decision summaries that the agency hopes may serve as a resource for other device makers hoping to submit devices for de novo review.

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