Search Results for digital health

Showing 1 – 10

Apple, Verily and J&J Among 9 Selected for FDA Digital Health Pilot By Zachary Brennan - Published 26 September 2017

US Food and Drug Administration Commissioner Scott Gottlieb took the stage Tuesday at AdvaMed’s MedTech conference in San Jose, California, unveiling the nine companies selected among 103 applicants to participate in the agency’s precertification pilot for digital health applications.

Categories: News, US, FDA, In vitro diagnostics, Medical Devices

Tags: Google, Verily, Johnson & Johnson, digital health, medical software

Help Wanted: FDA Seeks Digital Health Entrepreneurs By Zachary Brennan - Published 06 September 2017

Details of how the US Food and Drug Administration (FDA) is planning to tackle the growing digital health industry are slowly trickling out and on Wednesday the agency announced it will establish an Entrepreneur-in-Residence (EIR) Program to support and help develop its Software Precertification (PreCert) Pilot Program.

Categories: News, US, FDA, Government affairs, Medical Devices

Tags: digital health and FDA, precertification pilot

Professors Offer 3 Questions on FDA’s New Digital Health Framework By Zachary Brennan - Published 17 August 2017

The US Food and Drug Administration’s (FDA) recent push to reshape how it regulates digital health products with shifts to third-party certification and more postmarket reviews is called into question by three law professors in Health Affairs, who offer up three questions about the direction of the plan.

Categories: News, US, FDA, Government affairs, Medical Devices

Tags: digital health, pre-certification pilot

Apple Continues Push Into Device Industry With New Patent Filing By Zachary Brennan - Published 14 August 2017

Last week, tech behemoth Apple signaled its interest in further pursuing the development of medical devices with a new patent granted for an electronic device that "computes health data."

Categories: News, US, CDRH, In vitro diagnostics, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Apple, iPhone, mHealth, digital health

FDA Offers More Details on Digital Health Precertification Pilot By Zachary Brennan - Published 09 August 2017

The US Food and Drug Administration (FDA) this week sought to answer some frequently asked questions regarding the roll out of its new precertification pilot program for digital health products, which is expected to begin 1 September and only include nine participants.

Categories: News, US, FDA, In vitro diagnostics, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: digital health, precertification pilot for digital health, FDA digital health

FDA Updates on Digital Health Plans, Software Pre-Certification Pilot By Michael Mezher - Published 27 July 2017

The US Food and Drug Administration (FDA) on Thursday released new details on its plans for regulating digital health technologies, including more information about its upcoming pilot program to pre-certify software-based medical devices.

Categories: News, US, CDRH, Medical Devices, Submission and registration

Tags: Pre-Certification, PreCert Pilot, Software as a Medical Device, SaMD, Digital Health

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