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
fda-device · Food and Drug Administration · Rule · Published 1999-04-05 · Effective 1999-03-31 · 64 FR 16347
Document
Document number
99-8199
Federal Register citation
64 FR 16347
CFR reference
21 CFR 26
Type
Rule
Action
Final rule; correction.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
1999-04-05
Effective date
1999-03-31
HHS docket
Docket No. 98N-0185
Abstract
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.