Mutual Recognition of Pharmaceutical Good Manufacturing Practice Inspection Reports, Medical Device Quality System Audit Reports, and Certain Medical Device Product Evaluation Reports Between the United States and the European Community; Correction

The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of November 6, 1998 (63 FR 60122). The document amended FDA's regulations under an international agreement between the United States and the European Community. FDA took this action to enhance its ability to ensure the safety and effectiveness of pharmaceuticals and medical devices through more efficient utilization of its regulatory resources. The document was published with some inadvertent errors. This document corrects those errors.