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
Managing Pharmacovigilance in Digital Health Initiatives
Published 14 August 2015
This article analyzes adverse event reporting obligations and identifies ways to reduce regulatory risk and cost associated with digital health initiatives.
Categories: Articles, Features, US, FDA, Prescription drugs, Postmarket surveillance
Tags: pharmacovigilance, pharmaceutical, adverse events, adverse event reporting, digital health
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