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Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization
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Consumer Information on: AMPLATZER PFO Occluder
This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval. Product Name: AMPLATZER PFO OccluderPMA Applicant: St….
TAH-t Companion 2 Driver System (C2) and Freedom Driver System by SynCardia Systems: Letter to Health Care Providers
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UPDATE: SynCardia Systems – TAH-t Companion 2 Driver System (C2) and Freedom Driver System
Table 2. Patients Who Did NOT Receive Pre-Implant Circulatory Rescue Intervention (January 2016 report) Stroke and Other Neurological Adverse Events The most recent post-approval study results suggest that there is also a difference in clinical performance between the C2 Driver System and the CSS Console in terms of neurological adverse events. The INTERMACS Neurological…
Testosterone and Other Anabolic Androgenic Steroids (AAS): FDA Statement
[Posted 10/25/2016] AUDIENCE: Patient, Endocrinology, Internal Medicine ISSUE: FDA approved class-wide labeling changes for all prescription testosterone products, adding a new Warning and updating the Abuse and Dependence section to include new safety information from published literature and case reports regarding the risks associated with abuse and dependence of testosterone and other AAS. The Anabolic…
Waiver and Acknowledgment letters posted for November 9-10, 2016 Microbiology Devices Panel of the Medical Devices Advisory Committee
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FDA Voice blog: FDA is working with hospitals to modernize data collection about medical devices
Jeffrey Shuren, M.D., J.D., Director of FDA’s Center for Devices and Radiological Health By: Jeffrey Shuren, M.D., J.D. America’s hospitals and their dedicated staff helps us fight disease and suffering by delivering life-saving and life-enhancing care every day in an astounding variety of ways. From helping set a broken leg or responding to an emerging…
Public Workshop
The Food and Drug Administration (FDA) is announcing a public workshop entitled “The Role of Hospitals in Modernizing Evidence Generation for Device Evaluation: Harnessing the Digital Revolution for Surveillance.” Hospitals play a critical role in the development of these national capabilities, leading to more robust evidence generation. Recently, the role of hospital reporting of device-related…
Reporting Allegations of Regulatory Misconduct
An allegation of regulatory misconduct is a claim that a medical device manufacturer or individuals marketing medical devices may be doing so in a manner that violates the law. Reporting these allegations can help make the FDA aware of regulatory concerns it may not learn of otherwise. This information can help the FDA identify the…