Search Results for mobile

Showing 1 – 25  of 43

Wearable Technologies and Mobile Health Devices: Changing Medical Research and Delivering Better Patient Outcomes By Dr Elin Haf Davies, Chris Tyson - Published 28 August 2017

This article discusses how wearable technologies and mobile health devices are changing medical practice and improving patient outcomes with the potential to lower research and development costs and impact reimbursement.

Categories: Features, FDA, Medical Devices

Tags: Wearables, Mobile Health, mHealth, Patient Reported Outcomes

OPDP Study Raises Questions About the Balance of Information in Mobile Ads By Michael Mezher - Published 05 July 2017

A new study by officials from the US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) raises questions about the balance of benefit and risk information in mobile ads for prescription drugs.

Categories: News, US, FDA, Advertising and Promotion, Communication, Prescription drugs

Tags: OPDP, Office of Prescription Drug Promotion, Mobile Ads

Novel Trial Endpoints Generated by Mobile Tech: CTTI Offers Recommendations By Zachary Brennan - Published 26 June 2017

The Clinical Trials Transformation Initiative (CTTI), a public-private partnership established by Duke University and the US Food and Drug Administration (FDA), on Monday released new recommendations on developing novel clinical trial endpoints generated by mobile technology.

Categories: News, US, FDA, Clinical, Drugs, Medical Devices

Tags: CTTI, mobile technology and clinical trials, novel trial endpoints

FDA Issues Draft Q&A on Electronic Systems in Clinical Investigations By Michael Mezher - Published 20 June 2017

The US Food and Drug Administration (FDA) on Tuesday issued a draft questions and answers guidance to clarify expectations for using electronic systems, including electronic records, cloud computing and mobile technology, in clinical investigations.

Categories: News, US, FDA, Clinical

Tags: Electronic systems, Mobile technology

Popular RAPS App Back Again for 2016 Regulatory Convergence By Zachary Brousseau - Published 31 August 2016

The RAPS Events app offers users a convenient tool for finding information about sessions, speakers, events and activities; creating personalized agendas; accessing speaker presentation materials; reviewing sessions and speakers; participating in polls and surveys; and sharing comments and photos; as well as a fun way to earn points and prizes.

Categories: HTML, Articles, Under RAPS, RAPS

Tags: Regulatory Convergence, RAPS Events, mobile, app

FDA Declares ‘General Wellness’ Devices Exempt From Regulations By Michael Mezher - Published 28 July 2016

The US Food and Drug Administration (FDA) on Thursday finalized guidance saying that it does not plan to review low-risk "general wellness products", such as wearable fitness monitors or sleep trackers and will not require them to comply with premarket and postmarket regulatory requirements.

Categories: News, US, FDA, Government affairs, Medical Devices, Postmarket surveillance, Submission and registration

Tags: medical device regulation, health apps, mobile medical apps, mhealth, exercise equipment and FDA

Industry Calls for More Guidance From FDA on New Clinical Trials Technology By Zachary Brennan - Published 11 May 2016

The initiation of a new era of mobile health technology has erupted into industry calling on the US Food and Drug Administration (FDA) to offer more guidance on how best to use new technology, like Fitbits and mobile apps, in clinical trials, and to find ways that don’t restrict the development of novel tech products.

Categories: News, US, FDA, Clinical, Government affairs, Medical Devices, Research and development

Tags: Fitbit, mHealth, Medidata, Pfizer, GlaxoSmithKline, mobile health technology

FDA Collaborates With FTC on Mobile Health App Regulatory Tool By Zachary Brennan - Published 05 April 2016

The US Food and Drug Administration (FDA), the Federal Trade Commission (FTC) and other regulators are looking to help health-related mobile application developers comply with the Federal Food, Drug and Cosmetics Act (FD&C Act) and other applicable laws.

Categories: News, US, FDA, FTC, Business Skills, Compliance, Government affairs, Medical Devices

Tags: mHealth regulation, mobile health apps, health applications

EU Looks to Improve Data Quality of mHealth Apps By Zachary Brennan - Published 25 January 2016

The European Commission is bringing together a working group to develop guidelines by the end of 2016 for assessing the validity and reliability of the data that mobile health (mHealth) applications collect and process in order to make these ubiquitous apps more useful for public health.

Categories: News, Europe, US, EC, FDA, MHRA, Due Diligence, Government affairs, Medical Devices, Quality, Regulatory intelligence, Regulatory strategy

Tags: mHealth, mobile health apps, mobile health app data, mHealth regulations

FDA Seeks Info on New Tech Helping Conduct Clinical Research By Zachary Brennan - Published 28 October 2015

The US Food and Drug Administration (FDA) on Wednesday announced it's looking for more information on technologies and innovative ways to more efficiently conduct clinical research.

Categories: News, US, FDA, Clinical, Drugs, Research and development

Tags: clinical trials, informed consent, FDA, mobile technology

Convergence Attendees Can Use New RAPS Mobile App for Info, Fun and Prizes By Zachary Brousseau - Published 14 October 2015

Regulatory Convergence attendees will be able to use the new RAPS Events mobile app to find information about conference sessions, speakers, events and activities; share their own photos and comments; see updates from fellow attendees and earn prizes by completing certain activities.

Categories: HTML, Articles, Under RAPS, RAPS Events, RAPS

Tags: Regulatory Convergence, 2015 Regulatory Convergence, conference, mobile app

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

FDA Confirms it Won't Regulate Apps or Devices Which Store Patient Data By Alexander Gaffney, RAC - Published 06 February 2015

The US Food and Drug Administration (FDA) has put the finishing touches on a new policy which explains how it plans to regulate medical devices, including mobile apps, which track patient data and store patient images.

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

Tags: Mobile Medical Apps, FDA Mobile Apps, MDDS, MIDS, Medical Software, Guidance, Final Guidance

FDA Says It's Not Interested in Regulating Most Mobile Apps or Wearable Devices By Alexander Gaffney, RAC - Published 16 January 2015

Will the US Food and Drug Administration (FDA) ever regulate your FitBit, Apple iWatch or calorie-tracking mobile apps? Almost certainly not, the regulator confirmed today in a new draft policy document covering all "low-risk" general wellness devices.

Categories: News, US, CDRH, Medical Devices

Tags: Guidance, Draft Guidance, General Wellness Device, Wearable Device, Mobile Apps

One of FDA's Top Device Regulators Stepping Aside By Alexander Gaffney, RAC - Published 19 August 2014

One of the US Food and Drug Administration's (FDA) top medical device regulators, Christy Foreman, will soon be giving up her position to focus on tobacco regulation at the agency.

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

Tags: Christy Foreman, 510(k), Mobile App Regulation, Leaving, ODE

Medical Device Data Systems to be Exempt from Regulation, FDA Says By Alexander Gaffney, RAC - Published 20 June 2014

In a stark reversal, US Food and Drug Administration (FDA) regulators today said they would exempt medical device data systems (MDDS)—systems used to collect and store data from other medical devices like weight scales and glucose meters—from regulation, abandoning an earlier plan to regulate them as Class I ("low-risk") medical devices.

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

Tags: MDDS, Medical Device Data Systems, Exempt from Regulation, Mobile Medical Applications, Guidance, Draft Guidance, Medical Image Storage Device, Medical Image Communications Device

AHWP Proposes Regulating Health Software as Medical Devices, With Eye to Harmonization By Alexander Gaffney, RAC - Published 09 June 2014

The Asian Harmonization Working Party (AHWP), a regulatory group focused on the harmonization of regulations across Asia and various other emerging economies, has released for comment a new white paper regarding medical device software regulation in which it proposes the future regulation of software as a medical device (SaMD).

Categories: News, Asia, Medical Devices

Tags: AHWP, SaMD, Software as a Medical Device, Software, Medical Software, Mobile Medical Applications, Mobile Apps

There's an App for That: China FDA Launches Mobile Drug Regulation Application By Louise Zornoza, RegLink - Published 06 June 2014

The China Food and Drug Administration (CFDA) has launched a "national food and drug regulation" application, or "app," that permits the user to directly access the agency’s rules, regulations, working papers, drug quality announcements, medical device quality bulletins, drug and device recall information, and press releases.

Categories: News, China, CFDA, Compliance, Drugs, Product withdrawl and retirement

Tags: iPhone App, Android App, Software Application, Mobile App

Regulatory Explainer: Why and How is FDA Regulating Mobile Apps? By Alexander Gaffney, RAC - Published 15 April 2014

Categories: US, FDA

Tags: Mobile App Guidance, Medical App, Regulatory Explainer, Mobile Medical App, Mobile App, Latest News, medical device

FDA, ONC Issue Long-Awaited Health IT Framework By Alexander Gaffney, RAC - Published 03 April 2014

Categories: FDA

Tags: FDASIA Report, Health IT Report, ONC, Mobile Apps, FDASIA, Report, FCC, Latest News

UK Regulators Release Guidance on Software Apps By Alexander Gaffney, RAC - Published 20 March 2014

Categories: MHRA

Tags: Apps Guidance, Medical Software, Mobile Apps, Mobile Medical Applications, Software, Apps, Latest News, UK, guidance, EU

Senate Bill Would Exempt Most Software from FDA Regulation By Alexander Gaffney, RAC - Published 11 February 2014

Categories: US, FDA, CDRH

Tags: Medical Software, PROTECT Act, Mobile Medical App, SOFTWARE Act, Mobile App, Latest News, medical device

Mobile App Regulation Focus of Upcoming Legislative Hearing By Alexander Gaffney, RF News Editor - Published 18 November 2013

Categories: US, FDA

Tags: SOFTWARE Act, Mobile Health App, Mobile App, Latest News, Jeffery Shuren, medical device

Stubborn Drug Shortages Lead FDA to Develop Consumer-Focused Mobile App By Alexander Gaffney, RF News Editor - Published 31 October 2013

Categories: US, FDA

Tags: Mobile App, Drug Shortage, Latest News, Drug Shortages

Legislators Propose New Regulatory Definitions for Mobile Health Apps By Alexander Gaffney, RF News Editor - Published 23 October 2013

Categories: US, FDA

Tags: Mobile Medical Applications, Mobile App, Final Guidance, guidance