Pre-FDAAA malfunction reporting rules still in effect for Class I & II devices
This article was originally published in Clinica
The US Food and Drug Administration has clarified that manufacturers and importers of Class I (low-risk) and Class II (medium-risk) devices that are not permanently implantable, life-supporting or life-sustaining must continue submitting malfunction reports in full compliance with the agency's current regulations, despite the adoption of legal amendments that have relaxed these requirements.
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