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Center for Devices and Radiological Health

Government Technology/News
FDA, DHS Reunite to Address Cybersecurity Vulnerabilities in Healthcare Devices

The Food and Drug Administration and Department of Homeland Security have partnered to resolve cybersecurity issues in medical systems to maintain patient safety.

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by Monica Jackson
October 17, 2018
Government Technology
FDA Releases Final Guidance on Postmarket Mgmt of Medical Device Cybersecurity

The Food and Drug Administration has issued a final set of guidelines meant to help manufacturers secure medical devices from postmarket cyber vulnerabilities. Suzanne Schwartz, associate director for science and strategic partnerships at the

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by Jay Clemens
December 29, 2016
Government Technology
FTC, Partner Agencies Develop Web-Based Guidance Tool for Mobile Health App Developers

The Federal Trade Commission has launched a new web-based guidance tool for health-related mobile application developers. FTC’s guidance tool works to inform developers on the laws and regulations that apply to their mobile

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by Scott Nicholas
April 6, 2016
Government Technology/News
FDA’s Suzanne Schwartz: Medical Device Manufacturers Need to Protect Against Cybersecurity Risks

The U.S. Food and Drug Administration recommends that cybersecurity measures become an inherent part of medical device design and development in the recently released final guidance for device manufacturers on cybersecurity risk management.

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by Anna Forrester
October 2, 2014
Government Technology
FDA Issues Draft Guidance on Medical Device Data Systems, Image Storage Tech Policies

The Food and Drug Administration has released draft guidance for the health industry on the agency’s stance regarding regulatory compliance related to medical device data systems, medical image storage and communications devices.

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by Anna Forrester
June 25, 2014
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