Safety AnnouncementAdditional Information for PatientsAdditional Information for Healthcare ProfessionalsData Summary  Safety Announcement [07-21-2011] The U.S. Food and Drug Administration (FDA) is reviewing data from a clinical trial that was evaluating the effects of the antiarrhythmic drug Multaq (dronedarone) in patients with permanent atrial fibrillation. The study was stopped early after the data monitoring…
Unique Device Identification (UDI) for Postmarket Surveillance and Enforcement Public Workshop, September 12-13, 2011
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Guidance for Industry and Food and Drug Administration Staff
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Mammography Facility Adverse Event and Action Report
Background As part of the Mammography Quality Standards Act (MQSA), Congress mandated there be annual reporting of adverse actions taken against mammography facilities. Congress stipulated that the report be made available to physicians and the general public and that it should include information that is useful in evaluating the performance of mammography facilities nationwide. In…
Guidance for Industry and FDA Staff
Document issued on: July 20, 2011 For questions regarding this document contact Richard Felten at 301-796-6392 by email at [email protected]. U.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for Devices and Radiological Health General Surgery Devices Branch Division of Surgical, Orthopedic and Restorative DevicesOffice of Device Evaluation Preface Public Comment Written comments and…
June 2011
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Information on Mobile Medical Applications
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Draft Guidance for Industry and Food and Drug Administration Staff
DRAFT GUIDANCE Document Issued on: July 21, 2011 This guidance document is being distributed for comment purposes only. You should submit comments and suggestions regarding this draft document within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit written comments to the Division of Dockets…
Analysis of Premarket Review Times Under the 510(k) Program
Center for Devices and Radiological Health U.S. Food and Drug Administration TABLE OF CONTENTS Executive Summary Introduction Requests for Additional Information Additional Information Letter Analysis Study Methodology Results Submission Quality Increasing Number of Review Cycles Appropriate and Inappropriate Requests for Additional Information Additional Information Letters and NSE Decisions Conclusion Appendix I Executive Summary Recent reports…
AFLURIA
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