class III device

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class III device

Regulatory affairs A highly regulated 'high risk' medical device–eg, life-support or life-sustaining devices–eg, pacemakers and heart valves, approved by the FDA for use in humans; CIIIDs are also defined as those which pose a potentially unreasonable risk of illness or injury. See Medical device.

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premarket approval

The hearing aid is considered a Class III device by the FDA -- the most stringent regulatory category for devices.

FDA Seeks Civil Penalties from Hearing Aid Maker by ConsumerAffairs.com / consumeraffairs.com

The hearing aid is considered a Class III device by the FDA--the most stringent regulatory category for devices.

FDA seeks civil penalties from device maker by Adverse Event Reporting News

Section 510(k) of the MDA allows a Class III device to bypass the PMA requirement if the FDA deems it is "substantially equivalent" to a device that was marketed prior to 1976—the year the MDA took effect.

Riegel V. Medtronic: A Win For Medical Technology by Mondaq Business Briefing

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