Search Results for Software

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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

When to Submit a 510(k) (Devices and Software): A Regulatory Perspective By Jeff Ryberg - Published 21 March 2017

This article explores key elements of the US Food and Drug Administration's (FDA's) latest draft guidance to industry for deciding when to submit a new 510(k) for medical device hardware and software design changes. The potential business impact is assessed and suggestions are provided for what companies need to do to align with FDA's current thinking.

Categories: Features, US, FDA, Medical Devices, Submission and registration

Tags: 510(k), Software

FDA Releases Guidance on Software as a Medical Device for Consultation By Michael Mezher - Published 13 October 2016

The US Food and Drug Administration (FDA) on Thursday opened a public consultation on a harmonized guidance on the clinical evaluation of software as a medical device (SaMD) developed by the International Medical Device Regulators Forum (IMDRF).

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

Tags: Software as a Medical Device, SaMD, IMDRF, International Medical Device Regulators Forum

European Commission Offers Guidance on Standalone Software as a Medical Device or IVD By Zachary Brennan - Published 17 August 2016

The European Commission is offering guidance for device companies and other stakeholders trying to determine if their standalone software should be considered a medical device, in vitro diagnostic (IVD) or neither.

Categories: News, Europe, EC, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: standalone software as a medical device, European Commission guidance

FDA Issues Draft Guidance on 510(k) Device Modifications By Michael Mezher - Published 05 August 2016

The US Food and Drug Administration (FDA) on Friday released two draft guidances for public comment clarifying its policy for when manufacturers should submit a 510(k) for changes made to a medical device or its software.

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

Tags: 510(k), 510(k) Device Modification, Medical Device Software

IMDRF Offers Progress Updates at March Meeting By Zachary Brennan - Published 01 April 2016

The ninth meeting of the management committee of the International Medical Device Regulators Forum (IMDRF) took place in Brasília, Brazil, from 8 to 10 March 2016 and included high-level updates on how the group’s seven current work items are progressing and how device regulations are continuing to converge at the international level.

Categories: News, Asia, Canada, Europe, Latin America and Caribbean, Oceania, US, Anvisa, EC, EMA, FDA, Health Canada, IMDRF, MHLW, PMDA, WHO, Clinical, Compliance, Due Diligence, Government affairs, Manufacturing, Medical Devices, Quality

Tags: IMDRF, medical device regulations, MDSAP, international medical device regulations, medical software

FDA Calls on Device Manufacturers to Monitor, Report Some Postmarket Cybersecurity Vulnerabilities By Zachary Brennan - Published 15 January 2016

The prospect of a hacker or software vulnerability in a medical device causing serious harm to patients is pushing the US Food and Drug Administration (FDA) to require manufacturers to report a small subset of cybersecurity vulnerabilities that could compromise the clinical performance of a device, according to draft guidance released Friday.

Categories: News, US, FDA, Crisis management, Government affairs, Manufacturing, Medical Devices, Postmarket surveillance, Product withdrawl and retirement

Tags: cybersecurity, hacking medical devices, device software hacks, medical device malware

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

IMDRF Proposes QMS Principles for Software as a Medical Device By Michael Mezher - Published 08 April 2015

In recent years, general-purpose devices such as personal computers, smartphones and wearables have enabled the proliferation of “software as a medical device” (SaMD) products.

Categories: News, GHTF, IMDRF, ISO, Manufacturing, Medical Devices, Project management, Quality

Tags: Software as a Medical Device, SaMD, ISO 13845:2003, QMS

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

AHWP Finalizes Document Meant to Form Backbone of Software Regulation Approach By Alexander Gaffney, RAC - Published 31 October 2014

The medical-device focused Asian Harmonization Working Group (AHWP) has released a new document meant to eventually help provide a common approach for the regulation of medical device software.

Categories: News, Africa, Asia, Middle East, Medical Devices

Tags: AHWP, SaMD, Software, Software as a Medical Device, White Paper, Asian Harmonization Working Party

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

Congress Skeptical About FDA, ONC Effort to Coordinate on Health IT Regulation By Alexander Gaffney, RAC - Published 03 June 2014

In April of this year, the US Food and Drug Administration (FDA), along with the Office of the National Coordinator for Health Information Technology (ONC), issued a new proposed framework indicating their desire to more consistently regulate health technology, including health software. Now members of Congress have written to the ONC regarding that proposal, saying parts of it go above and beyond its authority under the law.

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

Tags: ONC, Office of the National Coordinator for Health Information Technology, Report, FDASIA, FDASIA Section 618, Software

IMDRF Proposes Framework for Regulating Device Software, Auditing Organizations By Alexander Gaffney, RAC - Published 02 April 2014

Categories: IMDRF, Audit

Tags: SaMD, MDSAP, Software, Latest News, medical device

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

A (Technologically Stunted) Ad/Promo Reviewer Looks at Techy Solutions to Regulatory Issues By Moulakshi Roychowdhury, PharmD, JD - Published 02 September 2013

Let's face it, regulatory advertising and promotion reviewers are generally not a technologically savvy demographic. Provided here is a brief review of three technology vendors that appear to provide optimal solutions to regulatory problems.

Categories: Features

Tags: adverse event tracker, risk information, software, technology

Regulating the Cloud: IMDRF Establishes Draft Definition of Standalone Medical Software By Alexander Gaffney, RF News Editor - Published 01 July 2013

Categories: IMDRF

Tags: Software, medical device

UK to Implement Risk-Based Software for Regulatory Inspections By Louise Zornoza, RegLink - Published 13 March 2013

Categories: MHRA

Tags: Software, UK, regulations, inspections, regulatory

Experts Examine Regulation of Health-Related Mobile Apps, Software and Social Media By Zachary Brousseau, RAPS senior manager, communications - Published 29 October 2012

When it comes to the regulation of mobile apps, software and social media in the healthcare space, intent is key but absolute clarity is elusive, according to the expert presenters who spoke to attendees during a session at 2012 RAPS: The Regulatory Convergence in Seattle.

Categories: Under RAPS, FDA, MHRA

Tags: Center for Medicine in the Public Interest, 2012 RAPS, Mobile Apps, Software, Mobile Health, regulators, social media, annual conference, The Regulatory Convergence, regulatory

Study: Security, Software Reporting Methods In Need of Improvement By Alexander Gaffney - Published 23 July 2012

Categories: Security

Tags: Software, Wireless, Latest News, study, medical device