Agency Information Collection Activities; Announcement of OMB Approval; Medical Devices; Third-Party Premarket Submission Review and Quality System Inspections Under United States/European Community Mutual Recognition Agreement

摘要

The Food and Drug Administration (FDA) is announcing that a collection of information entitled "Medical Devices; Third-Party Premarket Submission Review and Quality System Inspections Under United States/European Community Mutual Recognition Agreement" has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.