Search Results for health software

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FDA Backs Off From Regulating Certain Types of Health Software By Zachary Brennan - Published 07 December 2017

The US Food and Drug Administration (FDA) on Thursday unveiled three guidance documents – two draft and one final – that clarify which types of software will be regulated.

Categories: News, US, FDA, Government affairs, In vitro diagnostics, Medical Devices, Research and development

Tags: digital health, health software, 21st Century Cures

FDA Pilot to Sign Off on Low-Risk Digital Health Products Without Premarket Review By Zachary Brennan - Published 15 June 2017

US Food and Drug Administration (FDA) Commissioner Scott Gottlieb on Thursday announced an upcoming pilot program that would create a third-party certification program under which lower-risk digital health products could be marketed without FDA premarket review and higher-risk products could be marketed with a streamlined FDA review.

Categories: News, US, FDA, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: digital health, FDA digital health, software as a medical device

FDA to Create Digital Health Unit By Zachary Brennan - Published 04 May 2017

With ongoing work on guidance related to software as a medical device, and a new dedicated unit to digital health coming to the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH), the agency is slowly but surely dipping its toe into the rapidly advancing field.

Categories: News, US, CDRH, Medical Devices

Tags: digital health, software as a medical device, cybersecurity

Lingering Questions About Medical Apps By Michael Mezher - Published 09 July 2015

In recent years, the US Food and Drug Administration (FDA) has issued several guidance documents attempting to clarify its approach to regulating medical apps. However, the authors of "A regulatory framework emerges for digital medicine," a commentary appearing in Nature this week, raise several regulatory challenges remaining unanswered.

Categories: News, US, FDA, Clinical, Medical Devices, Regulatory strategy, Submission and registration

Tags: Medical apps, Medical applications, Mobile applications, digital health software, wearables