Meeting Notice: February 27, 2015 General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-N-0001] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY:  Food and Drug Administration, HHS. ACTION:  Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA).  The…

Public Workshop

The Food and Drug Administration (FDA) is announcing a public Workshop entitled: “Optimizing FDA’s Regulatory Oversight of Next Generation Sequencing Diagnostic Tests.” The purpose of this workshop is to discuss and receive feedback from the community on FDA’s regulatory approach to diagnostic tests for human genetics or genomics using Next Generation Sequencing (NGS) technology. Date,…

Prepare for GUDID

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Updated Information on Ultrasound Imaging

Description Uses Benefits/Risks Information for Patients including Expectant Mothers Information for Health Care Providers Information for Practices Conducting Ultrasound Imaging Information for Industry Reporting Problems to the FDA  Other Resources Benefits/Risks Ultrasound imaging has been used for over 20 years and has an excellent safety record. It is based on non-ionizing radiation, so it does not…

Transcripts Added to Public Workshop – Collaborative Approaches for Medical Device and Healthcare Cybersecurity, October 21

In recognition of National Cybersecurity Awareness Month, the Food and Drug Administration (FDA) in collaboration with the Department of Health and Human Services (HHS) and the Department of Homeland Security (DHS) is announcing a public workshop “Collaborative Approaches for Medical Device and Healthcare Cybersecurity.”  This workshop will bring together all stakeholders in the healthcare and…