PMA Final Decisions for October 2015

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Public Workshop – Moving Forward: Collaborative Approaches to Medical Device Cybersecurity, January 20-21, 2016

The Food and Drug Administration (FDA) is announcing the following public workshop titled “Moving Forward: Collaborative Approaches to Medical Device Cybersecurity.” FDA, in collaboration with the National Health Information Sharing Analysis Center (NH-ISAC), the Department of Health and Human Services and the Department of Homeland Security, seek to bring together diverse stakeholders to discuss complex…

PACS: An Ounce of Prevention…

Lately, when it comes to record retention, we have seen facilities laboring under some false assumptions: My facility’s Picture Archiving and Communication System (PACS) will last forever; its hard drives will never fail; my PACS doesn’t need to be backed-up and doesn’t need regular maintenance, refreshing, or upgrading. Although none of these statements is true,…

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…