Meanwhile, FDA's Center for Devices has directed field districts to begin surveillance inspections of a random sampling of Class I device makers to see how they are complying with GMPs and Quality Systems rules.

CDER eyes end of repeat warning letters; CDRH to spot-audit Class I ... by Inspection Monitor

Class I devices are those not intended for use in support of human life and offer little risk to human health.

Approval processes different for devices and drugs by McGivney, William T. / Physician Executive

The Food and Drug Administration (FDA) subsequently classified BioCurex's Histo-RECAF(TM) as a Class I device under Regulation Number 864.

The FDA Classification of BioCurex's Histo-RECAF Kit by Business Wire

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