Medical Devices; Draft Guidance for FDA Staff on Civil Money Penalty Policy; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Guidance for FDA Staff on Civil Money Penalty Policy.'' The civil money penalty (CMP) policy is intended for use by all FDA Regional and District Directors for the purpose of advising their field personnel when considering potential CMP recommendations under the Safe Medical Devices Act of 1990 (SMDA).